A clinical trial to study the effects of two drugs, dexmedetomidine , a drug used in tratment of raised blood pressure and for sedation and fentanyl, a drug used for pain relief and for sedation in patients undergoing spine surgery.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/08/035769
• Lead Sponsor: Dr Rakesh D R

Brief Summary

This study is a prospective, double blinded, randomised controlled study comparing the effect of dexmedetomidine and fentanyl on haemodynamic response in patients undergoing lumbar spine surgery under general anaesthesia. Spinal surgery represent a challenge to the anaesthesiologist as they are accompanied with many perioperative problems which includes fluctuation in blood pressure and severe postoperative pain , in this study we are looking for better drug for attenuating this complications.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-15
• Study Start: 2021-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 1.Consent to participate in study 2.American Society of Anaesthesiologist Grade I&II.
• 3.Patients undergoing lumbar spine surgeries under general anaesthesia.

Exclusion Criteria

• 1.Patients with disorder of cardiovascular, hepatic, renal or neuromuscular systems.
• 2.Patients with uncontrolled systemic diseases such as diabetes mellitus, hypertension, chronic obstructive lung disease9.
• 3.Patients on calcium channel blockers, beta blockers, chronic use of opioids.
• •Patients with BMI>35.10 •Patients receiving drugs known to interact with study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dexmedetomide is more effective than fentanyl in maintaining heamodynamic changes during lumbar spine surgery under general anaesthesia	24 weeks

Secondary Outcome Measures

Name	Time	Method
Side effects and complications are minimal with both the drugs	24 weeks

Trial Locations

Locations (1)

Jayarogya hospital; 🇮🇳 Gwalior, MADHYA PRADESH, India

Jayarogya hospital

🇮🇳Gwalior, MADHYA PRADESH, India

Dr Rakesh D R

Principal investigator

9148157239

rakeshdrajanna@gmail.com