To compare different doses of ketamine given during surgery to find best dose that provides adequate pain relief after the surgery

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2019/02/017540
• Lead Sponsor: Batra hospital and medical research centre

Brief Summary

Purpose of study: to determine optimal dose of intravenous ketamine given intraoperatively that provides adequate post operative analgesia with minimal side effects.

Background: inadequate post operative analgesia can lead to many complications. Opioids are the most common analgesic agents used but due their many adverse effects many other adjuncts are being investigated. Ketamine is a unique drug that provides analgesia at low doses, so side effects associated with high doses are avoided. Many authors have used different doses and optimal dose is not clear.

So we  designed this  comparative observational study where patients receiving different doses of intraoperative intravenous ketamine will be assessed for their postoperative analgesia requirements in the form of visual analogue scale scoring, time to first rescue analgesia and total opioid consumption in first 24 hours; and incidence of side effects.

There will be 4 groups:

group A: ketamine bolus of 0.1mg/kg followed by infusion@ 0.25 mg/kg/hr

group B: ketamine bolus of 0.2mg/kg followed by infusion@ 0.50 mg/kg/hr

group C: ketamine bolus of 0.3mg/kg followed by infusion@ 0.75 mg/kg/hr

group D: control group ( will recieve only paracetamol and diclofenac)

Patients in all the 4 groups will also receive paracetamol 15 mg/kg and diclofenac 1mg/kg as part of multimodal analgesia. Post operative supplemental analgesia will be provided with diclofenac 1mg/kg  8hourly and rescue analgesia as tramadol 1 mg/kg if visual analogue scale score exceeds 40.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patients Undergoing elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria

Patient refusal for inclusion into study group History of chronic opioid use or opioid abuse Psychiatric illness / Pregnancy / Morbid obesity Change from laparoscopic to open technique Poorly controlled hypertension or diabetes mellitus Unstable cardiovascular disease Severe Liver disease or renal disease Conditions with raised intracranial or intra-ocular pressure Allergy to study drugs.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ramsay Sedation scores	Time to extubation | Ramsay Sedation scores | Visual analogue scale score at rest and at movement | Time to first rescue analgesia | Total opioid consumption in 24 hours
Time to extubation	Time to extubation | Ramsay Sedation scores | Visual analogue scale score at rest and at movement | Time to first rescue analgesia | Total opioid consumption in 24 hours
Visual analogue scale score at rest and at movement	Time to extubation | Ramsay Sedation scores | Visual analogue scale score at rest and at movement | Time to first rescue analgesia | Total opioid consumption in 24 hours
Time to first rescue analgesia	Time to extubation | Ramsay Sedation scores | Visual analogue scale score at rest and at movement | Time to first rescue analgesia | Total opioid consumption in 24 hours
Total opioid consumption in 24 hours	Time to extubation | Ramsay Sedation scores | Visual analogue scale score at rest and at movement | Time to first rescue analgesia | Total opioid consumption in 24 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects – nausea, vomiting, delirium, hallucinations

Trial Locations

Locations (1)

Batra hospital and medical research centre; 🇮🇳 Delhi, DELHI, India

Batra hospital and medical research centre

🇮🇳Delhi, DELHI, India

Dr Khushbu Goel

Principal investigator

9780472490

khushi7708@gmail.com