Comparison between two different drugs in laproscopic surgery under general anesthesia

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis,

• Registration Number: CTRI/2023/11/059905
• Lead Sponsor: S Nijalingappa Medical College and HSK Hospital.

Brief Summary

Opioid free anaesthesia is the use of multimodal or balanced analgesia,the principle is to gain additive analgesic effects from different drugs while minimising side effects, particularly those of opioids.studies have shown that opioid free anaesthesia fast tracks surgery,reduces hospital stay, early mobilization and enteral nutrition.

The current study is planned to compare the analgesic and sedative effects of opioids (fentanyl) with opioid free drugs (lidocaine and dexmedetomidine)during perioperative period and to compare recovery characteristics and hemodynamics (heart rate and mean arterial pressure)as secondary outcome.

Inorder to provide adequate perioperative pain management the over use and over prescription of opioids have contributed to opioid crisis. Reports indicate that the number of overdose deaths from prescription and illicit opioids have quadrupled since 2000 from opioid addiction.

Improper opioid use , unsecure opioid storage and lack of appropriate disposal of unused or expired opioids increase the availability of these drugs for others to abuse and are major contributors to current opioid crisis . To overcome this FDA and department of justice drug enforcement administration have uniform guidelines regarding using ,storing and not sharing with others.FDA recommend that opioids are best disposed via medicine take back programs.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-11-15
• Study Start: 2023-12-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.ASA physical status 1 and 2 2.Age between 18 to 65 years 3.Patients undergoing laparoscopic surgeries under general anaesthesia.

Exclusion Criteria

1.History of opioid use 1 month prior to surgery 2.chronic opioid addiction 3.Inability to comprehend visual analogue scale 4.history of significant hepatic renal and cardiac disease 5.history of chronic pain and drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the heart rate and mean arterial pressure intraoperative with continuous lidocaine and dexmedetomidine infusion as opposed to conventional opioid based anaesthesia	24 hours

Secondary Outcome Measures

Name	Time	Method
1.postoperative pain in first 24 hours and time to rescue analgesia is compared in both groups	2.postoperative nausea vomiting assessment in both groups

Trial Locations

Locations (1)

S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL Bagalkot; 🇮🇳 Bagalkot, KARNATAKA, India

S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL Bagalkot

🇮🇳Bagalkot, KARNATAKA, India

Dr Chhaya Joshi

Principal investigator

9743320105

drchhayajoshi1@gmail.com