Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-03 @ 7:02 AM
Study NCT ID:
NCT06498869
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2024-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-07-06', 'studyFirstSubmitQcDate': '2024-07-06', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Ketamine on Sleep Quality Scores', 'timeFrame': 'Postoperative at 7.day', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Quality', 'Ketamine', 'Sleep', 'Sleep Habits', 'Anesthesia', 'Sedation', 'Colonoscopy'], 'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '38417951', 'type': 'BACKGROUND', 'citation': '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': '38039631', 'type': 'BACKGROUND', 'citation': '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': '36609213', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nParticipants are randomized into two groups: one receiving midazolam and propofol (control group), and the other receiving ketamine in addition to midazolam and propofol.\n\nProcedure 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.', 'detailedDescription': 'During colonoscopy procedures, routine procedural sedation and analgesia are typically administered due to expected severe discomfort and pain. Sedation is administered by anesthesiologists using various medications according to established clinical guidelines, such as those outlined by the Turkish Society of Anesthesiology and Reanimation. Typically, an initial dose of 2 mg of midazolam (0.025-0.1 mg/kg) is administered, followed by propofol. Propofol is initially given at a bolus dose of 0.5-1.0 mg/kg, followed by additional bolus doses of 0.25-0.5 mg/kg at intervals of 1-3 minutes as required to achieve and maintain sedation. Depending on clinical judgment, some clinicians may supplement with ketamine, known for its minimal respiratory depression effects, to reduce propofol dosage. Ketamine is administered at doses of 0.25-0.50 mg/kg for this purpose. All medications are administered intravenously, aiming for a moderate sedation scale of 1-3 (TARD Non-operating Room Anesthesia Practice Guidelines, March 2022, page 17).\n\nIn the study protocol, participants will undergo the following procedures based on these guidelines.\n\nParticipants who consent to participate in the study will undergo assessment using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Numeric Rating Scale for Sleep Quality, and Richards Campbell Sleep Questionnaire on the day of the procedure. This assessment will be conducted in person.\n\nParticipants will be randomized into two groups. One group will receive midazolam and propofol, constituting the control group. The other group will receive ketamine in addition to midazolam and propofol during the procedure.\n\nThe duration of the procedure and total medication doses will be documented. After the procedure, patients achieving a Modified Aldrete Score of 10 will be discharged to the recovery unit (TARD Non-operating Room Anesthesia Practice Guidelines, March 2022, page 17).\n\nData on participants will be recorded, and they will be contacted by phone 7 days post-procedure.\n\nParticipants will undergo reassessment using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Numeric Rating Scale for Sleep Quality, and Richards Campbell Sleep Questionnaire scales after the procedure.\n\nFollowing this assessment, participant follow-up will conclude. The effects of ketamine on sleep quality will be evaluated by comparing the values of the mentioned scales before and after the procedure.\n\nParticipants will be randomized into the Ketamine Group and Control Group in a 1:1 ratio. Randomization will be conducted using computer software by an independent researcher (AY). Randomization 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 participant follow-ups and assessments (BG) will remain blinded to each other. Participants and the researcher assessing sleep quality (BG) will be unaware of the treatment administered to participants. The study is designed as a double-blind trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agree to participate in the study\n* Patients undergoing colonoscopy procedures\n* Patients classified as ASA 1-2\n* Male and female patients aged 18-65 years\n\nExclusion Criteria:\n\n* Patients who decline to participate in the study\n* Patients allergic to ketamine, propofol, and midazolam\n* Patients with acute or chronic pain\n* Patients diagnosed with psychiatric disorders\n* Patients using antidepressants or sleep medications\n* Patients with sleep disorders\n* Patients with a history of oncological diseases\n* Patients experiencing complications related to colonoscopy procedures\n* Patients experiencing complications related to anesthesia administration\n* Patients with a body mass index (BMI) \\>30 kg/m²\n* Patients with cognitive impairment or communication issues\n* Pregnant and postpartum patients\n* Patients with sleep apnea syndrome\n* Patients with uncontrolled hypertension (Blood Pressure \\>180/110 mmHg)'}, 'identificationModule': {'nctId': 'NCT06498869', 'briefTitle': 'The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kocaeli City Hospital'}, 'officialTitle': 'The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy: A Prospective, Randomized, Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': 'KSH-ANREA-BG-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine Group', 'description': 'This group will receive ketamine (0.25-0.50 mg/kg) in addition to midazolam and propofol during the colonoscopy procedure', 'interventionNames': ['Drug: Ketamine Hcl 50Mg/Ml Inj']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'For this group, midazolam and propofol will be administered during the colonoscopy procedure. Ketamine will not be administered additionally.'}], 'interventions': [{'name': 'Ketamine Hcl 50Mg/Ml Inj', 'type': 'DRUG', 'otherNames': ['Ketalar, Registry Number: 690G0D6V8H, Unique ID D007649'], 'description': 'This group will be administered ketamine (0.25-0.50 mg/kg)', 'armGroupLabels': ['Ketamine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Kocaeli', 'state': 'Izmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli City Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'BEDİRHAN GÜNEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Upon reasonable request can be made to obtain patient data from the institution. Data will not be shared by the researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bedirhan Günel', 'investigatorAffiliation': 'Kocaeli City Hospital'}}}}