Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery

May 22, 2022 updated by: Lili Cao, Qianfoshan Hospital

Multimodal Analgesic Management of Naborphine Combined With Opioid Free Under General Anesthesia in OSA Patients Undergoing Weight Loss Surgery Under the Concept of ERAS: a Prospective, Randomized, Parallel Controlled Study

Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

  1. The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
  2. Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
  3. This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.

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 (Anticipated)

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.
48

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 Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Yongtao Sun

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA grade I ~ III;
  2. Age from 18 - 65 years old;
  3. BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.

Exclusion Criteria:

  1. Age < 18 years or age >65 years old;
  2. Pregnancy test was positive;
  3. Patients with a history of drug abuse or dependence on opioids;
  4. Patients with chronic pain or severe heart, lung, liver or nervous system diseases

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Other: Opioid anesthesia group
Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, sufentanil 0.3μg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and remifentanil 0.2-0.5 μg/kg·min to maintain anesthesia. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and sufentanil 10 μg will be given after surgery. For PCA, sufentanil 2μg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.
Procedure: Opioid free anesthesia technology
We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.
Experimental: Opioid free anesthesia group
Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, naborphine 0.2mg/kg，esketamine 0.3mg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and esketamine 0.3～0.5mg/kg·h. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and naborphine 0.2mg/kg will be given after surgery. For PCA, naborphine 2mg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.
Procedure: Opioid free anesthesia technology
We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.

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
postoperative NRS score
Time Frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score and cough NRS score at different postoperative time will be used.
Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.

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
Dosage of remedial analgesics postoperatively
Time Frame: It takes about 24 hours.
If the participant still feels severe pain after operation and needs additional analgesic drugs for treatment, we will record the type and dose of drugs used by the patient.
It takes about 24 hours.
Hemodynamic fluctuation
Time Frame: From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
Hemodynamic fluctuation during perioperative period. The levels of SBP in mmHg, DBP in mmHg, MAP in mmHg and HR in times/minute in basic(T0), after induction(T1), preoperative(T2) and after establishing pneumoperitoneum(T3) 1h after the pneumoperitoneum(T4) and Immediately after operation(T5), Before(T6) and after(T7) extubation were recorded.
From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
Ramsay scale
Time Frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
Ramsay scale is the most widely used sedation scoring standard in clinic, which is simple and practical. This scale has multiple advantages: it is reproducible, easily executed and has good applicability. This has made the scale the most widely used to assess level of sedation for procedures in pediatrics. It is divided into six levels(1-6): 1 shows patient is anxious and agitated or restless, or both; 2 shows patient is co-operative, oriented, and tranquil; 3 shows patient responds to commands only; 4 shows patient exhibits brisk response to light tactile stimuli or loudauditory stimulus; 5 shows patient exhibits sluggish response to light tactile stimuli or loud auditory stimulus; 6 shows patient exhibits no response.
Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
recovery time
Time Frame: It will take up to 1 hour or 2 hours.
From the time when the patient entered PACU to the time when the participant meets the standard of leaving the PACU.
It will take up to 1 hour or 2 hours.
The levels of C-reactive protein (CRP)
Time Frame: It takes about 24 hours.
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of C-reactive protein (mg/L).
It takes about 24 hours.
The levels of cortisol (COR).
Time Frame: It takes about 24 hours.
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of cortisol (nmol/L).
It takes about 24 hours.
The levels of blood glucose (BG)
Time Frame: It takes about 24 hours.
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of blood glucose (mmol/L).
It takes about 24 hours.
The levels of interleukin-6 (IL-6).
Time Frame: It takes about 24 hours.
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of IL-6 (pg/mL).
It takes about 24 hours.
Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.
Time Frame: One day after the surgery.
The QoR-15 scale is a validated tool to assess the quality of postoperative recovery (QoR) from 0 to 150. The QoR was classified as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 < 90).
One day after the surgery.
Rate of postoperative nausea and vomiting
Time Frame: It takes about 24 hours.
Postoperative nausea and vomiting will be recorded if it happens.
It takes about 24 hours.
Acceptability of participants with laryngeal mask 24 hours after surgery.
Time Frame: One day after the surgery.
One day after surgery, we will record the acceptability of laryngeal mask and the degree of postoperative pharyngeal pain of the participants. Acceptability of participants with laryngeal mask will be assessed by whether the participant was willing to receive laryngeal mask anesthesia again. Pharyngeal pain can be evaluated using the Numeric Pain Scale (NRS) pain numerical score. A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).
One day after the surgery.

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.
Qianfoshan Hospital

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: Yongtao Sun, doctor, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

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 (Anticipated)

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 15, 2022

Primary Completion (Anticipated)

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.
January 31, 2023

Study Completion (Anticipated)

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.
October 31, 2023

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).
May 10, 2022

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.
May 22, 2022

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.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

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.
May 24, 2022

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.
May 22, 2022

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.
May 1, 2022

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.
  • YXLL-KY-2022(035)

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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