The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy

NCT06498869 | Completed

• 1 other identifier: KSH-ANREA-BG-02
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep Quality; Ketamine; Sleep; Sleep Habits; Anesthesia; Sedation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Effects of Ketamine on Sleep Quality Scores

  Ketamine, a dissociative anesthetic commonly used in medical and veterinary settings, has shown potential benefits for sleep quality, particularly in individuals with chronic pain or depression. Its primary mechanism involves blocking NMDA receptors in the brain, which not only provides anesthesa and pain relief but also impacts brain regions responsible for regulating sleep. Pittsburgh sleep quality index 0-21. RICHARD CAMPBELL sleep quality 0-100.SLEEP QUALITY NUMERICAL RATING SCALE 0-10.

  Postoperative at 7.day

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

This group will receive ketamine (0.25-0.50 mg/kg) in addition to midazolam and propofol during the colonoscopy procedure

Drug: Ketamine Hcl 50Mg/Ml Inj

Control Group

NO INTERVENTION

For this group, midazolam and propofol will be administered during the colonoscopy procedure. Ketamine will not be administered additionally.

Interventions

Ketamine Hcl 50Mg/Ml Inj DRUG

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

Also known as: Ketalar, Registry Number: 690G0D6V8H, Unique ID D007649

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agree to participate in the study
• Patients undergoing colonoscopy procedures
• Patients classified as ASA 1-2
• Male and female patients aged 18-65 years

You may not qualify if:

• Patients who decline to participate in the study
• Patients allergic to ketamine, propofol, and midazolam
• Patients with acute or chronic pain
• Patients diagnosed with psychiatric disorders
• Patients using antidepressants or sleep medications
• Patients with sleep disorders
• Patients with a history of oncological diseases
• Patients experiencing complications related to colonoscopy procedures
• Patients experiencing complications related to anesthesia administration
• Patients with a body mass index (BMI) \>30 kg/m²
• Patients with cognitive impairment or communication issues
• Pregnant and postpartum patients
• Patients with sleep apnea syndrome
• Patients with uncontrolled hypertension (Blood Pressure \>180/110 mmHg)

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (3)

• Yang Y, Zhang Y, Zhou G, Yang Z, Yan H, Zhang J. Efficacy of epidural esketamine on postoperative sleep quality after laparoscopic and robotic lower abdominal surgeries: a study protocol for randomised, double-blind, controlled trial. BMJ Open. 2024 Feb 27;14(2):e081589. doi: 10.1136/bmjopen-2023-081589.

  PMID: 38417951 BACKGROUND

• Cui M, Xing T, Zhao A, Zheng L, Zhang X, Xue H, Wu Z, Wang F, Zhao P. Effects of intraoperative sodium oxybate infusion on post-operative sleep quality in patients undergoing gynecological laparoscopic surgery: A randomized clinical trial. J Clin Anesth. 2024 May;93:111349. doi: 10.1016/j.jclinane.2023.111349. Epub 2023 Dec 1.

  PMID: 38039631 BACKGROUND

• Qiu Y, Hou H, Zhang J, Wang X, Wang L, Wu Y, Deng L. The effect of preoperative sleep quality on the target plasma concentration of propofol and postoperative sleep in patients undergoing painless gastroscopy. BMC Anesthesiol. 2023 Jan 7;23(1):9. doi: 10.1186/s12871-022-01957-2.

  PMID: 36609213 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• BEDİRHAN GÜNEL

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be conducted by an independent researcher (AY) using computer software and will be securely stored in sealed envelopes. An independent researcher (AŞ) will open the envelope 30 minutes prior to the procedure. The researcher administering anesthesia and the researcher conducting patient follow-ups and assessments (BG) will be blinded to each other. The participants will also be unaware of their assigned study group. Consequently, both the participants and the researcher assessing sleep quality (BG) will be blinded to the treatment administered. The study will be designed as a double-blind study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Our participants will be randomized into two separate groups. One group will receive midazolam and propofol, which will be our control group. The other group will receive ketamine in addition to midazolam and propofol during the procedure.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: July 30, 2024
• Primary Completion: September 16, 2024
• Study Completion: October 6, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)