Low-Dose Ketamine Infusion for Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy

NCT06966596 | Completed Phase 1

• 1 other identifier: FPRMC-IRB-2024-38
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. At low dosages (\<0.3 mg/kg/hr) and large doses (\>1 mg/kg), ketamine is utilized as an analgesic and an anaesthetic. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. Although this medication is a powerful analgesic, its usage is restricted due to it leads to agitation and hallucinations during awakening. Nevertheless, it has a potent analgesic effect when administered at a subanesthetic dose, and ketamine's psychomimetic side effects are rare at these dosages. This study intended to examine the role of low-dose for post-operative pain control in patients undergoing LC, despite the fact that numerous studies have been conducted on the subject and that the results have been inconsistent.

Conditions

Laparoscopic Cholecystectomy

Keywords

Cholelithiasis; Cholecystectomy; Laparoscopic surgery; Ketamine; Analgesia

Outcome Measures

Primary Outcomes (1)

• Post-pain assessment

  pain was assessed using numeric rating scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no pain and 10 means worst pain.

  pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours

Secondary Outcomes (1)

• time to rescue analgesia

  till 24 hours post-operatively

Study Arms (2)

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.

EXPERIMENTAL

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery.

Drug: Ketamine only

Control Group B

PLACEBO COMPARATOR

Control group received normal saline intravenously at an equivalent infusion rate

Other: Placebo Normal Saline (NS)

Interventions

Ketamine only DRUG

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. W

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.

Placebo Normal Saline (NS) OTHER

Control group received normal saline to maintain double blinding

Control Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 18 years or above of either gender
• Patients planned of elective laparoscopic choleycyctectomy

You may not qualify if:

• Obese patients
• History of alcohol consumption and drug abusers
• Uncontrolled hypertension
• Uncontrolled diabetes
• Patients with chronic pain
• Patients allergic to study drugs
• Patients with neurological disorders
• Patients unable to understand scoring system

Sponsors & Collaborators

• Fazaia Ruth Pfau Medical College: lead

Study Sites (1)

Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal

Karachi, Pakistan

Location

Related Publications (3)

• Jain S, Nazir N, Mustafi SM. Preemptive low-dose intravenous ketamine in the management of acute and chronic postoperative pain following laparoscopic cholecystectomy: a prospective randomized control study. Med Gas Res. 2022 Oct-Dec;12(4):141-145. doi: 10.4103/2045-9912.337995.

  PMID: 35435425 BACKGROUND

• Akturk R, Serinsoz S. Determining a Method to Minimize Pain After Laparoscopic Cholecystectomy Surgery. Surg Laparosc Endosc Percutan Tech. 2022 Aug 1;32(4):441-448. doi: 10.1097/SLE.0000000000001071.

  PMID: 35797664 BACKGROUND

• Gin E, Lowen D, Tacey M, Hodgson R. Reduced Laparoscopic Intra-abdominal Pressure During Laparoscopic Cholecystectomy and Its Effect on Post-operative Pain: a Double-Blinded Randomised Control Trial. J Gastrointest Surg. 2021 Nov;25(11):2806-2813. doi: 10.1007/s11605-021-04919-0. Epub 2021 Feb 9.

  PMID: 33565010 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Agnosia

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)