A study to evaluate the effect of dexmedetomidine for general anaesthesia considering the weight of the patient

Phase 4

Recruiting

• Conditions: ASA I & II patients, between age group18-60yrs with BMI of 30kg/m2 and above, undergoing elective laparoscopic surgery under general anaesthesia for atleast 30 minutes and maximum of 3 hours

• Registration Number: CTRI/2018/05/013885
• Lead Sponsor: Dr L H Hiranandani Hospital

Brief Summary

This is prospective randomised comparative study to evaluate optimal intravenous dose of dexmedetomidine ( bolus and maintenance) based on total body weight and ideal body weight for laparoscopic surgeries.

Many drugs behave differntly in obese and non obese patients, the reason being both pharmacokinetics and pharmacodynamics properties of drugs. Dexmedetomidine may have varied effects in obese and non obese patients. There is no common consensus or literature retgarding correct weight scalar for dosing dexmedetomidine. There is no proportionate linear relationship in the increament of total body weight , adipose tissue and other body compartments like muscle , tissues etc. The volume of distribution also different and thus the drug dosing differs in obese patients. Hence we would like to evaluate the best weight scalar for bolus and maintenance dose of dexmedetomidine.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1 Patients undergoing elective laparoscopic surgery 2 With BMI between 30kg/m2 and above 3 ASA 1and 2 under general anaesthesia 4 Duration of 30 minutes to maximum of 3 hours 5 Informed consent.

Exclusion Criteria

• 1.History of significant cardiac pulmonary, liver or renal disease.
• Patient scheduled for awake bronchoscopic intubation.
• Previous history of cerebrovascular accident, other neurological disorders and those on long term drugs affecting CNS (chronic BZD’s/ opioids) 4.
• Allergy to dexmedetomidine .
• Patients with significant hemodynamic changes intraoperatively, fall of Mean arterial blood pressure by more than 20% of baseline, 6.
• Intraoperative entropy of more than 60 for more than 10 minutes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ideal weight scalar for assessing dose of intravenous dexmedetomidine for the haemodynamic stability during general anaesthesia during the duration of laprascopic surgery	Intraoperatively during surgery

Secondary Outcome Measures

Name	Time	Method
Recovery parameters like	1 Sedation score post extubation

Trial Locations

Locations (1)

Dr L H Hiranandani Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

Dr L H Hiranandani Hospital

🇮🇳(Suburban), MAHARASHTRA, India

Dr Meenoti Potdar

Principal investigator

9920627839

meenoti@gmail.com