A study for safe anaesthesia in laparoscopic surgeries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/09/045427
• Lead Sponsor: Vijaynagar institute of medical sciences

Brief Summary

This study is a randomised controlled double blinded study,compares the haemodynamic effects i.e mean arterial pressure as primary outcome in TIVA anaesthetic technique with TCI propofol wherein comparator group  fixed dose of intravenous infusion of fentanyl and in intervention group   fixed dose intravenous infusion of dexmedetomidine is used in laparoscopic surgries.The secondary outcomes  that will be studied are correlation of state entropy values and TCI propofol,total dosage of propofol used and assesment of postop nausea and vomiting.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

American society of Anaesthesiologists physical status 1 to 2 Non obese(BMI 18.5 to 29).

Exclusion Criteria

Refusal of patient consent Patients with significant systemic diseases Patients on long term and concurrent sedative intake.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of haemodynamic parameters during laparoscopy (with changes in mean arterial pressure as primary objective)	1)on arrival to operating room,2)after bolus doses of test drugs,3)pre induction,4)post intubation (1 min, 2min, 5min,10min),5)at initiation of pneumo insufflation, 6)post pneumo- insufflation, 7)every 5 minutes till end of procedure;8)after removal of trocar, 9)stop of propofol infusion , 10)administration of reversal, 11)at extubation, 12)1 min, 2min, 5min and10min following extubation till shift out to Post anesthesia care unit (PACU)

Secondary Outcome Measures

Name	Time	Method
correlation of TCI propofol with the state entropy levels i.e the effecctor site concentration value of propofol and corresponding state entropy values	Effector site concentration of propofol and corresponding state entropy values measured
total propofol dose used	at the end of surgery
Postop nausea and vomiting assesment in PACU and postop wards by PONV Impact scale (4 point likert scale) along with vomiting counts	IN PACU AND postop wards,every 2nd hourly for 24 hours

Trial Locations

Locations (1)

Vijaynagar institute of medical sciences; 🇮🇳 Bellary, KARNATAKA, India

Vijaynagar institute of medical sciences

🇮🇳Bellary, KARNATAKA, India

Sumith Dhulange

Principal investigator

8217424749

sumithdhulange649@gmail.com