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

NCT06175156 | Completed DMC

• 1 other identifier: 2023-L-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcotism

Outcome Measures

Primary Outcomes (1)

• Auditory evoked potential

  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 Outcomes (1)

• The time from after surgery to OAA/S score reached 5 and Aldrete score reached 9

  through study completion，an average of 2 hours

Other Outcomes (2)

• Intraoperative noninvasive blood pressure (MAP)

  through study completion，an average of 2 hours

• Pulse oximetry were monitored continuously Saturation (SPO2)

  through study completion，an average of 2 hours

Study Arms (2)

Controlled analgesia/sedation (PCAS) group

EXPERIMENTAL

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

Intravenous combined anesthesia group

ACTIVE COMPARATOR

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

Interventions

Controlled analgesia/sedation PROCEDURE

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

Controlled analgesia/sedation (PCAS) group

Intravenous combined anesthesia PROCEDURE

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.

Intravenous combined anesthesia group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Handan First Hospital: lead

Study Sites (1)

Handan First Hospital

Handan, Hebei, 056000, China

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)