Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (OS-PCC)

January 2, 2026 updated by: Göteborg University

Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery

The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy.

The overall aim is to evaluate the short-, medium- and long-term effects of opioid-free care pathways with or without person-centred care compared to conventional opioid-based treatment in patients undergoing obesity surgery.

Specific aims

  1. Determine the effects of opioid-free care with or without person-centred care compared with conventional opioid-based general anaesthesia on the cognitive and physical quality of recovery after surgery up to 24 months after surgery (short-term: postoperative to discharge, medium-term: 14 days, 3 months, long-term: 6 months, 12 months and 24 months).
  2. Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.
  3. Map the impact of opioid-free anaesthesia (with and without person-centred care) on the usage of opioids up to 24 months after hospital discharge.
  4. Explore the patients' experience of quality of life, economic evaluations, self-efficacy and recovery after surgery in opioid-free care with or without person-centred care during the first year post-surgery.

The aims will be evaluated by a prospective, randomized, non-blinded, non-commercial multi-centre study (Nov 2018-Dec 2022) approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim To evaluate the effects of opioid sparing care pathways compared to conventional opioid-based treatment for pain relief, opioid consumption, recovery after surgery, self-efficacy and health economy in patients undergoing obesity surgery. The aim will be investigated by a prospective, randomized, non-blinded, non-commercial multi-centre study(Nov 2018-Dec 2022), approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).

Hypothesis 1. An opioid-free care pathway provides non-inferior pain relief as the conventional care with opioids during the post-operative phase.

Primary endpoints: Determine the quality of recovery after surgery

1. No difference in pain (NRS pain (0-10)) between opioid-free intervention with or without (Phase 1 & 2) person-centred care and conventional treatment (control group) during the postoperative phase until discharge to the surgical ward.

Secondary endpoints:

An opioid-sparing treatment provides improved combined outcomes (composite score) consisting of 1) Self-Efficacy, 2) Postoperative Quality of Recovery Scale (PQRS), hospital readmission, or death at 3 months compared to conventional treatment.

An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment.

An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment.

An opioid-sparing treatment results in decreased pain experience according to the Numeric Rating Scale (NRS) at 3 months and 6 months compared to conventional treatment.

An opioid-sparing treatment leads to earlier recovery after surgery measured with PQRS compared to conventional treatment postoperatively (20 minutes, 40 minutes), during hospitalization (24-72 hours), and thereafter (14 days, 30 days, 3 months, 6 months, 12 months, and 24 months).

An opioid-sparing treatment increases confidence in coping with unexpected events measured with the General Self-Efficacy Scale compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months).

An opioid-sparing treatment improves quality of life measured with RAND-36 and EQ5D compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months)

An opioid-sparing treatment results in equivalent length of hospital stay compared to conventional treatment during the in-hospital period.

Mapping of long-term prescription of analgesic drugs. Does an opioid-sparing treatment impact the long-term use of analgesic medications.

Explorative endpoints:

Describe the intraoperative nociception level between opioid-free anaesthesia and conventional anaesthesia using the Medasense PMD-200 (NOL) monitor.

Economic evaluation: Performing cost-utility analysis/ cost-effectiveness analyses.

Power Pain: To determine noninferiority with a power of 0.8 (i.e., the probability of > 0.8 for the lower limit of a two-sided 95% confidence interval (using Fisher's nonparametric permutation test)), the difference of change in pain using the NRS from arrival to the recovery unit after surgery to discharge from the recovery unit will be used. Forty-three patients are required in each group and phase, with an SD for the change in the NRS estimated to be 1.62 from a small pilot study (noninferiority margin -1.0). The estimated change was assumed to be equal in the groups. To compensate for a potential interruption in the study or dropouts, we chose to include 55 patients in Intervention Phase 1, 55 patients in Intervention Phase 2 and a total of 110 patients in the control group (to follow intervention Phases 1 and 2, each 55 patients).

Recovery after surgery: To detect an overall difference in the quality of recovery between groups over the entire study length, with a power of 0.8 and P < 0.05 and taking into consideration a dropout of over 30% as seen in other studies using the PQRS, we need to include at least 30 patients in each group 26.

The control group will receive usual care and treatment according to the hospital's routines, where pain relief is obtained with opioids postoperatively. Pharmacological treatment in the intervention group differs solely from the patients in the usual group by replacing opioids with the following nonopioid perioperative treatment: dexmedetomidine, esketamine, lidocaine and TENS (for exact dosing, please visit EU-CT 2023-505934-86-00). Postoperative patient-controlled pain treatment with high-intensity/high-frequency TENS is used if the patient perceives pain over NRS ≧ 3 postoperatively and during remaining hospitalisation.

Intervention Phase 1 tests the pharmacological and non-pharmacological interventions (TENS) compared to the control group that receives standard care with opioids intra- and postoperatively. Phase 2 intervention that follows after completion of Phase 1 intervention tests the pharmacological and nonpharmacological interventions compared to conventional treatment, supplemented by an evidenced-based PCC approach throughout the continuum of postoperative care.

The two phases will primarily be analysed separately (i.e., between the control group and intervention Phase 1 and between the control group and intervention Phase 2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Axel Wolf, RN, PhD
  • Phone Number: +46709355364
  • Email: axel.wolf@gu.se

Study Locations

  • Sweden
    • Region Örebro
      • Lindesberg, Region Örebro, Sweden, 711 82
    • VG
      • Gothenburg, VG, Sweden, 41678
        • Recruiting
        • Sahlgrenska University hospital/ Östra hopsital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.

Exclusion Criteria:

  • ASA> III
  • Cardiovascular disease with bradycardia (<50 bpm)
  • Serious liver disease failure
  • Insufficient knowledge of the Swedish language
  • Serious untreated psychiatric disease
  • Neurocognitive dysfunction
  • Pregnancy
  • Women of childbearing age without contraception
  • Malignant disease with expected short survival
  • Patients treated with opioids for chronic pain
  • Substance abuse
  • Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine
  • Pacemaker or ICD
  • Inability to fill in questionnaires
  • Decline participation,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control

Control group: The patients receive the routine based anesthesiological treatment during bariatric surgery (Gastric By-Pass or Sleeve Gastrectomy). It consists of:

General anesthesia induction: TCI Remifentanil Cpt 6 ng/ml/ Cp 3.2 ng/m, Propofol 1.5-2 mg/kg iv, Desflurane/Sevuflurane MAC (0.6-0.8).

Maintained by Desflurane MAC (0.6-0.8) adjusted via BIS (40-60) and Remifentanil Cp 4-10 ng/ml.

Post-operative pain management: Oxycodone 2.5 mg iv if the pain is rated by patient NRS ≧3. Paracetamol 1 g/6 h and Diclofenac 80 mg/24 h.
Drug: Remifentanil
The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.
Other Names:
  • Ultiva
Drug: Propofol
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
Drug: Oxycodone
The control group receives Oxycodone as the routine pain management drug post-operative.
Drug: Desflurane
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
Other Names:
  • Desfluran
Experimental: Intervention

Induction: Dexmedetomidine 0.2 micrograms/kg/h iv 5 min+16 mcg, Esketamine 0.1mg/kg + Propofol 1.5-2 mg/kg iv, Desflurane/Sevuflurane MAC (0.6-0.8).

Maintained by Desflurane/Sevuflurane MAC (0.6-0.8) BIS (40-60), Dexmedetomidine 0.2 micrograms/kg/h, Esketamine 0.1-0.3mg/kg/h och 0.1 mg/kg in case of hypertension. End of surgery, Lidocaine 1 mg/kg iv (max 4 mg/kg /4 h), Midazolam 0.5mg

Post-operative: Dexmedetomidine (0.1-0.2 micrograms/kg/h up to 4 h post-operative). If the pain is rated NRS ≧3: Transcutaneous Nerve Stimulation (TENS) with high intensive 40-50 mA for 1 minute, if the patient still NRS ≧3, the TENS treatment is repeated one more time. If pain NRS ≧3 after two treatments with TENS: Esketamine 0.1mg/kg iv + Lidocaine 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS still ≧3 within 30 minutes after both TENS and Esketamine/Lidocaine, 2.5 mg Oxycodone iv until NRS < 3. Perioperative and at discharge, PCC will be used for the the intervention (Phase 2 patients)
Drug: Propofol
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
Drug: Dexmedetomidine
The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Other Names:
  • Dexdor
Drug: Esketamine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Other Names:
  • Ketanest
Drug: Lidocaine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment.
Other Names:
  • Xylocaine
Device: Transcutaneous Nerve Stimulation (TENS)
The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.
Other Names:
  • TENS
Behavioral: Person-centred care (PCC)
The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge. This will be part of patients in Phase 2
Other Names:
  • Phase 2
Drug: Desflurane
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
Other Names:
  • Desfluran

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward.
Time Frame: From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward
Post-operative phase until discharge to the surgical ward. Pain assessed according to change in NRS (numeric rating scale). NRS (numeric rating scale for pain), (ranging from 0-10, "no pain" vs. "worst imagined pain").
From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery after surgery
Time Frame: (20 min, 40 min), during hospitalization (24 hours-72 hours) and afterwards (14 days, 30 days, three months, six months, 12 months and 24 months)

Investigating recovery after surgery measured with the The Post-operative Quality of Recovery Scale (PostopQRS) compared with conventional postoperative therapy.

PostopQRS: Is a validated 5-dimensional instrument (Physiology, Nociception, Emotion, Cognition, ADL) in addition to questions about patient satisfaction.

The scoring of recovery is 'return to baseline values or better' which requires a change score ≥ 0 for each question. The postoperative value for each test ( Cognition has a 2 scale tolerance due to day-to-day variation) is subtracted from the baseline value, and if no difference, then the patient is recovered.
(20 min, 40 min), during hospitalization (24 hours-72 hours) and afterwards (14 days, 30 days, three months, six months, 12 months and 24 months)
Average opioid consumption perioperative
Time Frame: From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge
Investigating opioid consumption during the peri- and post-operative care period compared with conventional treatment until discharge from the hospital and up to 24 months discharge.
From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge
Length of hospital stay
Time Frame: Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days
Length of indexed hospital stays calculated as the mean length in days from admission to discharge
Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days
Change in general Self-Efficacy
Time Frame: 3 months, six months, 12 months, 24 months.

Investigating patient change in self-efficacy, measured with the General Self-Efficacy Scale (GSES). GSES is a validated questionnaire that contains 10 questions about the person's experiences of trust in his / her ability to handle difficult situations. The patient is asked to estimate his ability on a 4-point scale (1 not true) to 4 (true).

The 10 answers are summed and a mean is calculated. Higher scores are better.
3 months, six months, 12 months, 24 months.
Change in Quality of Life
Time Frame: (3 months, six months, 12 months, 24 months)

Investigating the quality of life measured with the RAND-36

RAND-36: The RAND-36 is a health-related quality of life (HRQoL) It is comprised of 36 items assessing eight areas: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.

Each item is scored 0-100, and are than summarized. 0 is low, 100 is the highest score to get.
(3 months, six months, 12 months, 24 months)
Exploring patient experience
Time Frame: 2 weeks after hospital discharge

Investigating patient experience and satisfaction during the hospital stay, measured with the PPE-15, a 15 item questionnaire. The PPE15 is a validated short version of The Picker Care experience survey (40 item).

Each item has response alternatives ranging from no problem, some problem, problem. Each response is coded either as "a problem" ( problem, some problem) or as "no problem". Problem is scored as=1, no problem=0. The mean is calculated both on item level and as a total score.
2 weeks after hospital discharge
Change in health status
Time Frame: (3 months, six months, 12 months, 24 months)

Investigating the change in health status measured with the EuroQol 5 dimension (EQ5D).

EQ-5D is a standardized instrument for measuring generic health status, covering five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Each dimension has 3 responses: no problems, some problems, and extreme problems. This response results into a number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
(3 months, six months, 12 months, 24 months)
Unplanned re-admission
Time Frame: From time of surgery up until 24 months post-surgery
Investigating re-admission (un-planned) between groups.
From time of surgery up until 24 months post-surgery
Mortality
Time Frame: From time of surgery up until 24 months post-surgery
Investigating mortality rate between groups.
From time of surgery up until 24 months post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Economic evaluation
Time Frame: During hospital stay and up to 24 months
Performing cost-utility analysis/ cost-effectiveness
During hospital stay and up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sven-Egron Thörn, MD, PhD, Göteborg University
  • Study Chair: Axel Wolf, RN, PhD, Professor, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OS-PCC-2017
  • 2017-003830-97 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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