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

Fazaia Ruth Pfau Medical College

Status and phase: Completed; Phase 1

Conditions: Laparoscopic Cholecystectomy

Treatments: Other: Placebo Normal Saline (NS); Drug: Ketamine only

Study type: Interventional

Funder types: Other

Identifiers

NCT06966596

FPRMC-IRB-2024-38

Details and patient eligibility

About

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.

Full description

Most patients still stay overnight after a laparoscopic cholecystectomy (LC) due to post-operative pain, which continues to be the principal obstacle to early patient discharge. On the first postoperative day following laparoscopic procedures, patients may have mild to moderate postoperative pain, with decreased pain intensity in the shoulder area (from the subdiaphragmatic region), particularly intra-abdominal and local discomfort at the incision site. Because of its analgesic properties and cardiovascular stability, ketamine has been used extensively in anesthesia practice. It non-competitively blocks N-methyl-D-aspartate (NMDA) receptors. As an addition to multimodal perioperative pain management, ketamine has grown in favor in recent years. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. In a range of surgical procedures, low-dose ketamine infusions (<0.3 mg/kg/hr) have demonstrated effectiveness in lowering pain scores and minimising the need for postoperative opioids. Regarding the reduction of pain and analgesic demand, ketamine has demonstrated conflicting effects. The study objective was to determine the effect of low-dose ketamine infusion on quality and duration of post-operative pain in patients undergoing laparoscopic in a tertiary care hospital.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: Ketamine only

Control Group B

Placebo Comparator group

Description:

Control group received normal saline intravenously at an equivalent infusion rate

Treatment:

Other: Placebo Normal Saline (NS)