Application of Propofol Mixed With Remifentanil in Fiber Colonoscopyand Analgesia in Fiber Colonoscopy

December 8, 2023 updated by: Yonghua Song, Handan First Hospital

The Application of Propofol and Remifentanil Mixed Solution for Controlled Sedation and Analgesia in Fiber Colonoscopy

Fiber colonoscopy, as a terminal examination method for lower gastrointestinal diseases, often brings varying degrees of pain, discomfort, tension, and anxiety to patients. Therefore, currently in clinical practice, intravenous anesthesia is often chosen to reduce discomfort. At present, intravenous propofol and fentanyl are most widely used in clinical practice, but intravenous general anesthesia can lead to hemodynamic fluctuations and an increase in anesthesia related complications such as prolonged hospital stay after surgery. Propofol and remifentanil have the characteristics of fast onset, short duration of action, and rapid awakening. The purpose of this study is to observe the efficacy and adverse reactions of remifentanil combined with low-dose propofol in patient-controlled analgesia and sedation during colonoscopy, in order to explore the safety and effectiveness of this method.

Study Overview

Status

Status

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

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

Fibercolonoscopy, as a terminal examination method for lower digestive tract diseases, often brings different degrees of pain and discomfort, tension and anxiety to patients. Therefore, at present, intravenous anesthesia is often used in clinical practice to reduce discomfort, and intravenous propofol combined with fentanyl is the most widely used in clinical practice. But intravenous general anesthesia can lead to hemodynamic fluctuations and an increase in anesthesiation-related complications such as longer stays in the hospital after surgery. Complications related to sedation and analgesia have attracted increasing attention in recent years. Studies have shown that most of the adverse events in endoscopy are related to the sedation and analgesia drugs used. With the successful application of patient-controlled analgesia (PCA) in the field of postoperative analgesia, this technique has also been used in the sedation and analgesia of gastroenteroscopy in recent years. Propofol has the characteristics of quick action, short time of action and rapid recovery, so it is very suitable for the anesthesia and sedation of painless abortion and painless gastroenteroscopy. Remifentanil, as an opioid μ receptor agonist, is easily hydrolyzed rapidly by non-specific esterases in plasma and tissues due to the ester bond contained in its chemical structure. Therefore, it has unique pharmacokinetic characteristics such as rapid intravenous injection, small volume of distribution, rapid clearance after drug withdrawal, no accumulation, metabolism is not affected by liver and kidney function, and has been widely used in various surgeries in recent years, especially in the anesthesia of short surgeries.

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 (Actual)

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.
80

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
    • Hebei
      • Handan, Hebei, China, 056000
        • Handan First Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Grade I - II;
  2. Age 18-75 years old;
  3. Body mass index (BMI) <25㎏/㎡;
  4. no mental and nervous system diseases;

Exclusion Criteria:

  1. Refusal to cooperate or difficulty communicating;
  2. History of drug allergy;
  3. Long-term alcoholism and dependence on stabilizing and opioid drugs;
  4. Patients with past history of intestinal surgery or past difficulty in endoscopic surgery;
  5. People with hearing impairment

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: Supportive Care
  • 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.
Experimental: Controlled analgesia/sedation (PCAS) group
Each group of patients is required to open the right upper limb venous access as a routine, take the left side lying position, and continuously inhale oxygen with a mask at a flow rate of 8L/min, while connecting various monitoring devices. During the pre anesthesia assessment, explain in detail to the patient the usage of the self-control pump and confirm that each patient can master it. Firstly, connect the self-control analgesic pump with a loading dose of 3 ml. Then, continuously pump in a mixture of propofol and remifentanil at a speed of 0.1 ml/kg/h. After the loading dose is completed, the examination can begin. During the operation, press the self-control handle according to the patient's sensation. Each press can quickly push 1ml of the medication, with a locking time of 1 minute.
Procedure: Controlled analgesia/sedation
During the pre anesthesia assessment, explain in detail to the patient the usage of the self-control pump and confirm that each patient can master it. Firstly, connect the self-control analgesic pump with a loading dose of 3 ml. Then, continuously pump in a mixture of propofol and remifentanil at a speed of 0.1 ml/kg/h. After the loading dose is completed, the examination can begin. During the operation, press the self-control handle according to the patient's sensation. Each press can quickly push 1ml of the medication, with a locking time of 1 minute
Active Comparator: Intravenous combined anesthesia group
Each group of patients is required to open the right upper limb venous access as a routine, take the left side lying position, and continuously inhale oxygen with a mask at a flow rate of 8L/min, while connecting various monitoring devices. Intravenous slow infusion of fentanyl 1 μ G/kg, midazolam 0.02mg/kg, slowly administer propofol 0.8-1mg/kg after 2 minutes (time greater than 60 seconds), and start the examination when the patient's consciousness disappears and they do not respond. During the surgery, propofol is interrupted to maintain the auditory evoked potential index (AAI) between 30-40.
Procedure: Intravenous combined anesthesia
Intravenous slow infusion of fentanyl 1 μ G/kg, midazolam 0.02mg/kg, slowly administer propofol 0.8-1mg/kg after 2 minutes (time greater than 60 seconds), and start the examination when the patient's consciousness disappears and they do not respond. During the surgery, propofol is interrupted to maintain the auditory evoked potential index (AAI) between 30-40.

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
Auditory evoked potential
Time Frame: through study completion，an average of 2 hours
The auditory evoked potential (AEPI) is a reactive electrical activity of the brain generated by auditory stimuli, reflecting the entire electrical activity from the cochlea to the cerebral cortex.Before taking anesthesia, check Record the AEPI values at 5 time points before anesthesia, at the beginning of the examination, during endoscopy to the splenic curvature, ileocecal region, and at the end of the examination.
through study completion，an average of 2 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
The time from after surgery to OAA/S score reached 5 and Aldrete score reached 9
Time Frame: through study completion，an average of 2 hours
Evaluation and score were performed every minute after operation The time from surgery to OAA/S score of 5 and Aldrete score of 9 were recorded
through study completion，an average of 2 hours

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
Intraoperative noninvasive blood pressure (MAP)
Time Frame: through study completion，an average of 2 hours
Intraoperative noninvasive blood pressure (MAP) were monitored by nasal catheterization (ETCO2)
through study completion，an average of 2 hours
Pulse oximetry were monitored continuously Saturation (SPO2)
Time Frame: through study completion，an average of 2 hours
pulse oximetry were monitored continuously Saturation (SPO2)were monitored by nasal catheterization (ETCO2)
through study completion，an average of 2 hours

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.
Handan First Hospital

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.
March 1, 2023

Primary Completion (Actual)

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.
August 1, 2023

Study Completion (Actual)

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.
September 1, 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).
November 30, 2023

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.
December 8, 2023

First Posted (Estimated)

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.
December 18, 2023

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.
December 18, 2023

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.
December 8, 2023

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.
December 1, 2023

More Information

Terms related to this study

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.
  • 2023-L-001

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

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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