Laparoscopic CholecystectomyketamineNCT07900854
Effects of Bolus Versus Infusion Ketamine During Laparoscopic Cholecystectomy
A study testing ketamine bolus, ketamin infusion and Normal Saline in people with Laparoscopic Cholecystectomy and Optic Nerve Sheath Diameter Measurement, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled study evaluated the effects of different ketamine administration strategies in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Optic Nerve Sheath Diameter Measurement, Ketamine
- What is being tested?
- ketamine bolus, ketamin infusion and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 2022
- 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
- Age between 18 and 65 years
- Scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I or II
- Body weight ≥45 kg
- Body mass index (BMI) >18 kg/m² and <32 kg/m²
- Provision of written informed consent
Who cannot join
- Refusal to participate in the study
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- History of malignancy
- Severe cardiovascular or cerebrovascular disease, including congestive heart failure, myocardial infarction, or previous stroke
- Hepatic or renal dysfunction
Show all 10Show fewer
- Pregnancy or lactation
- Intracranial space-occupying lesion or any condition associated with increased intracranial pressure
- Known optic nerve pathology
- Intraoperative complications requiring discontinuation from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ İstanbul Bağcılar Training and Research Hospital
Istanbul
About this study
Official title: THE EFFECT OF ADDING KETAMINE BY BOLUS OR INFUSION TO ANESTHESIA MAINTENANCE IN CASE OF LAPAROSCOPIC CHOLECYSTECTOMİES ON İNTRACRANİAL PRESSURE, SEVOFLURAN CONSUMPTION AND POSTOPERATIVE ANALGESIS, RANDOMIZED CONTROLLED STUDY
This prospective, randomized, controlled study evaluated the effects of different ketamine administration strategies in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were randomized into three groups: bolus ketamine, continuous ketamine infusion, or control without ketamine. The study investigated the effects of these strategies on optic nerve sheath diameter measured by ultrasonography as a surrogate marker of intracranial pressure, intraoperative sevoflurane consumption, and postoperative pain and analgesic requirements.
- Conditions
- Laparoscopic Cholecystectomy, Optic Nerve Sheath Diameter Measurement, Ketamine, Postoperative Pain
- Being tested
- ketamine bolus, ketamin infusion, Normal Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine bolusDrug
Ketamine 0.25 mg/kg was administered intravenously as a bolus after the initiation of remifentanil infusion following endotracheal intubation. The same dose was repeated if the duration of surgery exceeded 60 minutes.
ketamin infusionDrug
Ketamine was administered intravenously at 0.25 mg/kg/hour after the initiation of remifentanil infusion following endotracheal intubation and was continued until the end of surgery.
Normal SalineOther
Participants in the control group did not receive ketamine. A 100 mL normal saline infusion was initiated concurrently with the remifentanil infusion.
| Study group | Role | What they receive |
|---|---|---|
| Bolus Ketamine Group | Experimental | Participants received intravenous ketamine 0.25 mg/kg as a bolus after induction of anesthesia. The dose was repeated if the duration of surgery exceeded 60 minutes. Receives: Drug: ketamine bolus |
| Ketamine Infusion Group | Experimental | Participants received intravenous ketamine at 0.25 mg/kg/hour, initiated after induction of anesthesia and continued until the end of surgery. Receives: Drug: ketamin infusion |
| Control Group | Placebo comparator | Participants did not receive ketamine and received 100 mL normal saline according to the study protocol. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter
Optic nerve sheath diameter (ONSD) was measured using ocular ultrasonography. Measurements were obtained bilaterally at 3 mm posterior to the globe, and the mean of four consecutive measurements was recorded. ONSD was evaluated to assess changes associated with different ketamine administration strategies during laparoscopic cholecystectomy.
Measured: Pre-anesthesia; 5 minutes after intubation; 5 minutes after initiation of the study intervention; 5 minutes after pneumoperitoneum; 5 minutes after reverse Trendelenburg positioning; 30 minutes after intubation; and 5 minutes after desufflation.
Optic Nerve Sheath Diameter
Measured: Pre-anesthesia; 5 minutes after intubation; 5 minutes after initiation of the study intervention; 5 minutes after pneumoperitoneum; 5 minutes after reverse Trendelenburg positioning; 30 minutes after intubation; and 5 minutes after desufflation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2021
- Primary completion4 Apr 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ÖZGE PEKŞEN KIZILIŞIK, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900854
- Sponsor's protocol ID
- E-10840098-772.02-6143
- Acronym
- ketamine
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ADDING KETAMINE BY BOLUS OR INFUSION TO ANESTHESIA MAINTENANCE IN CASE OF LAPAROSCOPIC CHOLECYSTECTOMİES ON İNTRACRANİAL PRESSURE, SEVOFLURAN CONSUMPTION AND POSTOPERATIVE ANALGESIS, RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07900854
- Acronym / sponsor ID
- ketamine / E-10840098-772.02-6143
- Conditions
- Laparoscopic Cholecystectomy, Optic Nerve Sheath Diameter Measurement, Ketamine, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Oct 2026 (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.
This prospective, randomized, controlled study evaluated the effects of different ketamine administration strategies in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were randomized into three groups: bolus ketamine, continuous ketamine infusion, or control without ketamine. The study investigated the effects of these strategies on optic nerve sheath diameter measured by ultrasonography as a surrogate marker of intracranial pressure, intraoperative sevoflurane consumption, and postoperative pain and analgesic requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bolus Ketamine Group | Experimental | Drug: ketamine bolusParticipants received intravenous ketamine 0.25 mg/kg as a bolus after induction of anesthesia. The dose was repeated if the duration of surgery exceeded 60 minutes. |
| Ketamine Infusion Group | Experimental | Drug: ketamin infusionParticipants received intravenous ketamine at 0.25 mg/kg/hour, initiated after induction of anesthesia and continued until the end of surgery. |
| Control Group | Placebo comparator | Other: Normal SalineParticipants did not receive ketamine and received 100 mL normal saline according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I or II
- Body weight ≥45 kg
- Body mass index (BMI) >18 kg/m² and <32 kg/m²
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- History of malignancy
- Severe cardiovascular or cerebrovascular disease, including congestive heart failure, myocardial infarction, or previous stroke
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 bolusKetamine 0.25 mg/kg was administered intravenously as a bolus after the initiation of remifentanil infusion following endotracheal intubation. The same dose was repeated if the duration of surgery exceeded 60 minutes. | Drug | Bolus Ketamine Group |
| ketamin infusionKetamine was administered intravenously at 0.25 mg/kg/hour after the initiation of remifentanil infusion following endotracheal intubation and was continued until the end of surgery. | Drug | Ketamine Infusion Group |
| Normal SalineParticipants in the control group did not receive ketamine. A 100 mL normal saline infusion was initiated concurrently with the remifentanil infusion. | Other | Control Group |
Primary outcome
Optic Nerve Sheath Diameter
Time frame: Pre-anesthesia; 5 minutes after intubation; 5 minutes after initiation of the study intervention; 5 minutes after pneumoperitoneum; 5 minutes after reverse Trendelenburg positioning; 30 minutes after intubation; and 5 minutes after desufflation.
Optic nerve sheath diameter (ONSD) was measured using ocular ultrasonography. Measurements were obtained bilaterally at 3 mm posterior to the globe, and the mean of four consecutive measurements was recorded. ONSD was evaluated to assess changes associated with different ketamine administration strategies during laparoscopic cholecystectomy.
Optic Nerve Sheath Diameter
Time frame: Pre-anesthesia; 5 minutes after intubation; 5 minutes after initiation of the study intervention; 5 minutes after pneumoperitoneum; 5 minutes after reverse Trendelenburg positioning; 30 minutes after intubation; and 5 minutes after desufflation.
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 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Cholecystectomy
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 bolus, ketamin infusion and Normal Saline in people with Laparoscopic Cholecystectomy and Optic Nerve Sheath Diameter Measurement, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research 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 6 inclusion and 10 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 30 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
Optic Nerve Sheath Diameter (time frame: Pre-anesthesia; 5 minutes after intubation; 5 minutes after initiation of the study intervention; 5 minutes after pneumoperitoneum; 5 minutes after reverse Trendelenburg positioning; 30 minutes after intubation; and 5 minutes after desufflation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.