Analgosedation for Elective Colonoscopy

NCT05421962 | Completed Phase 1

• 1 other identifier: KMA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim of the study was to to compare the analgesic effects of ketamine over fentanyl combined with propofol in analgesia-based elective colonoscopy with purpose of patient safety and satisfaction. Methods: This is a double-blinded prospective randomized controlled trial. Ninety patients were included and randomized to either fentanyl-propofol (Group FP, n: 30), ketamine-propofol (Group KP, n: 30) or propofol-control group (Group C, n: 30). Group FP patients received fentanyl and propofol, Group KP received ketamine and propofol and Group C, propofol. In all groups, incremental doses of propofol were used to maintain a Ramsay sedation score (RSS) of 5. Respiratory depression, hemodynamic parameters were monitored for the first minute and every 5 minutes during endoscopy. Fifteen minutes after the procedure, the degree of pain was assessed using a visual analog scale (VAS), the quality of recovery according to the Aldrete score (ARS), complications during and after the procedure and additional doses of propofol were recorded.

Conditions

Pain; Side Effect

Keywords

analgesic; ketamine; fentanyl; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Degree of the pain

  15 minutes after the procedure, the degree of pain was assessed using a visual analog scale (VAS).The scale is horizontal, ungraded, bounded at both ends by vertical lines that define the extreme limits of the indicators being measured. The experienced pain sensation were marked by the patient on a scale, and then the marked position were assigned a numerical value according to the VAS score as follows: VAS score: no pain 0-10 mm; mild pain 10-30 mm; moderate pain 30-70 mm; severe pain 70-100 mm.

  15 minutes

Study Arms (3)

Midazolam and Fentanyl

EXPERIMENTAL

Patients were premedicated with 0.05 mg kg-1 of midazolam (PanPharma), 5 minutes before the starting of the procedure. Afterwards, sedation induction was performed with 1 mcg kg-1 of fentanyl (Panpharma; SanMed) and 0.5 mg kg-1 of propofol (Fresenius Kabi; Amicus Pharma).

Drug: Ketamine

Midazolam and Ketamine

EXPERIMENTAL

Patients were premedicated with 0.05 mg kg-1 of midazolam (PanPharma), 5 minutes before the starting of the procedure. Afterwards, sedation induction was performed with ketamine (Inresa Arzneimittel) 0.5 mg kg-1 and 0.5 mg kg-1 of propofol.

Drug: Ketamine

Midazolam and Propofol

NO INTERVENTION

Patients were premedicated with 0.05 mg kg-1 of midazolam (PanPharma), 5 minutes before the starting of the procedure. Afterwards, sedation induction was performed with 1 mg kg-1 of propofol.

Interventions

Ketamine DRUG

Ninety patients were included and randomized to either fentanyl-propofol (Group FP, n: 30), ketamine-propofol (Group KP, n: 30) or propofol-control group (Group C, n: 30). Group FP patients received fentanyl and propofol, Group KP received ketamine and propofol and Group C, propofol.

Also known as: Fentanyl

Midazolam and Fentanyl; Midazolam and Ketamine

Eligibility Criteria

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

You may qualify if:

• ASA physical statuses I and II,
• patients who were older than 18 years

You may not qualify if:

• colonoscopies lasting longer than 30 minutes,
• patients with previous abdominal surgery,
• patients treated for neuropathic pain, malignant and respiratory diseases,
• pregnant women, gastrointestinal obstruction,
• patients using antihypertensive and antiarrhythmic drugs,
• psychiatric patients,
• patients with ASA physical status III and higher,
• patients who refused to participate in the study

Sponsors & Collaborators

• Cantonal Hospital Zenica: lead

Study Sites (1)

Cantonal Hospital

Zenica, 72000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: January 1, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

BO (1)