Skip to content

Effects of Bolus Versus Infusion Ketamine During Laparoscopic Cholecystectomy

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07900854
Acronym
ketamine
Enrollment
102
Registered
2026-10-28
Start date
2021-12-01
Completion date
2022-12-01
Last updated
2026-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy, Optic Nerve Sheath Diameter Measurement, Ketamine, Postoperative Pain

Brief summary

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.

Interventions

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.

DRUGketamin infusion

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.

OTHERNormal Saline

Participants in the control group did not receive ketamine. A 100 mL normal saline infusion was initiated concurrently with the remifentanil infusion.

Sponsors

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Optic Nerve Sheath DiameterPre-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 31, 2026