SleepNCT06498869
The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy
A study testing Ketamine Hcl 50Mg/Ml Inj in people with Sleep, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep
- What is being tested?
- Ketamine Hcl 50Mg/Ml Inj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2024to 6 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy: A Prospective, Randomized, Controlled, Double-Blind Study
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.
Read more
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.
Read the 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 (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).
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 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.
- Conditions
- Sleep
- Being tested
- Ketamine Hcl 50Mg/Ml Inj
- Keywords
- Sleep Quality, Ketamine, Sleep, Sleep Habits, Anesthesia, Sedation, Colonoscopy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hcl 50Mg/Ml InjDrug
Also called Ketalar, Registry Number: 690G0D6V8H, Unique ID D007649
This group will be administered ketamine (0.25-0.50 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative at 7.day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start30 Jul 2024
- Primary completion16 Sep 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bedirhan Günel, Kocaeli City Hospital
- Investigators
- BEDİRHAN GÜNEL, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498869
- Sponsor's protocol ID
- KSH-ANREA-BG-02
- Status last verified
- Oct 2024
- First submitted
- 6 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request can be made to obtain patient data from the institution. Data will not be shared by the researchers.
Publications
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.
PubMed 38417951Cui 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.
PubMed 38039631Qiu 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.
PubMed 36609213
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketamine on Sleep Quality in Patients Undergoing Colonoscopy: A Prospective, Randomized, Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT06498869
- Acronym / sponsor ID
- KSH-ANREA-BG-02
- Conditions
- Sleep
- Keywords
- Sleep Quality, Ketamine, Sleep, Sleep Habits, Anesthesia, Sedation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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).
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Active comparator | Drug: Ketamine Hcl 50Mg/Ml InjThis group will receive ketamine (0.25-0.50 mg/kg) in addition to midazolam and propofol during the colonoscopy procedure |
| Control Group | No intervention | –For this group, midazolam and propofol will be administered during the colonoscopy procedure. Ketamine will not be administered additionally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine Hcl 50Mg/Ml InjAlso: Ketalar, Registry Number: 690G0D6V8H, Unique ID D007649This group will be administered ketamine (0.25-0.50 mg/kg) | Drug | Ketamine Group |
Primary outcome
Effects of Ketamine on Sleep Quality Scores
Time frame: Postoperative at 7.day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 38417951Yang 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.
- Background: PubMed 38039631Cui 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.
- Background: PubMed 36609213Qiu 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.
- Individual participant dataSharing planned: No. Upon reasonable request can be made to obtain patient data from the institution. Data will not be shared by the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BEDİRHAN GÜNEL principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Hcl 50Mg/Ml Inj in people with Sleep, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Ketamine on Sleep Quality Scores (time frame: Postoperative at 7.day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.