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The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy

NCT06498869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-10-09

No results posted yet for this study

Summary

Sedation typically begins with 2 mg of midazolam (0.025-0.1 mg/kg), followed by propofol given initially at 0.5-1.0 mg/kg bolus doses, with additional 0.25-0.5 mg/kg boluses as needed every 1-3 minutes to maintain sedation. Depending on clinical judgment, ketamine may be added to minimize propofol doses due to its minimal respiratory depression effects, administered at 0.25-0.50 mg/kg.

In the study protocol, participants undergo comprehensive assessments using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Numeric Rating Scale for Sleep Quality, and Richards Campbell Sleep Questionnaire on the procedure day, conducted in person.

Participants are randomized into two groups: one receiving midazolam and propofol (control group), and the other receiving ketamine in addition to midazolam and propofol.

Procedure duration and medication doses are meticulously recorded. Post-procedure, patients with a Modified Aldrete Score of 10 are transferred to the recovery unit. Participant data are documented, with follow-up conducted via phone 7 days post-procedure. Participants are reassessed using the aforementioned scales after the procedure, concluding the initial follow-up. The effects of ketamine on sleep quality will be evaluated by comparing the values of the mentioned scales before and after the procedure.

Conditions

  • Sleep

Interventions

DRUG

Ketamine Hcl 50Mg/Ml Inj

This group will be administered ketamine (0.25-0.50 mg/kg)

Sponsors & Collaborators

  • Kocaeli City Hospital

    lead OTHER_GOV

Principal Investigators

  • BEDİRHAN GÜNEL · Kocaeli City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2024-09-16
Completion
2024-10-06

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06498869 on ClinicalTrials.gov