Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498869
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Brief Title:
The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy
Sponsor:
Kocaeli City Hospital
Organization:
Kocaeli City Hospital
Study Overview
Official Title:
The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy A Prospective Randomized Controlled Double-Blind Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sedation typically begins with 2 mg of midazolam 0025-01 mgkg followed by propofol given initially at 05-10 mgkg bolus doses with additional 025-05 mgkg 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 025-050 mgkg
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
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
Detailed Description:
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 0025-01 mgkg is administered followed by propofol Propofol is initially given at a bolus dose of 05-10 mgkg followed by additional bolus doses of 025-05 mgkg 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 025-050 mgkg 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
In the study protocol participants will undergo the following procedures based on these guidelines
Participants 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
Participants 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
The 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
Data on participants will be recorded and they will be contacted by phone 7 days post-procedure
Participants 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
Following 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
Participants will be randomized into the Ketamine Group and Control Group in a 11 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
In the study protocol participants will undergo the following procedures based on these guidelines
Participants 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
Participants 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
The 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
Data on participants will be recorded and they will be contacted by phone 7 days post-procedure
Participants 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
Following 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
Participants will be randomized into the Ketamine Group and Control Group in a 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None