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CompletedNCT07900854ketamineUpdated Oct 30, 2026

Effects of Bolus Versus Infusion Ketamine During Laparoscopic Cholecystectomy

An interventional study of ketamine bolus and ketamin infusion in Laparoscopic Cholecystectomy, Optic Nerve Sheath Diameter Measurement and Ketamine, sponsored by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Dec 2021, registered Oct 2026).
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Pain, Postoperative

5,259 studies on the registry are indexed under Pain, Postoperative; 1,163 are open to participants now.

This study's enrollment of 102 is above the median of 75 across 4,490 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Bolus Ketamine Group

    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.

    Drug: ketamine bolus

  • Experimental
    Ketamine Infusion Group

    Participants received intravenous ketamine at 0.25 mg/kg/hour, initiated after induction of anesthesia and continued until the end of surgery.

    Drug: ketamin infusion

  • Placebo comparator
    Control Group

    Participants did not receive ketamine and received 100 mL normal saline according to the study protocol.

    Other: Normal Saline

Interventions

  • Drugketamine bolus

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

07

Study locations

1 site
  • SBÜ İstanbul Bağcılar Training and Research Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 2 updates
  1. Oct 30, 2026
    Minor edits only
    + 1 other change: identifiers
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900854
Lead sponsor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Responsible party
ÖZGE PEKŞEN KIZILIŞIK (Anesthesiology and Reanimation Specialist, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital) — Principal investigator
First posted
Oct 28, 2026
Start date
Dec 1, 2021
Primary completion
Apr 4, 2022
Completion
Dec 1, 2022
Last update
Oct 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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