Effects of adding fentanyl versus tramadol with hyperbaric bupivacaine for spinal anaesthesia in urological surgeries.

Phase 4

Not yet recruiting

• Registration Number: CTRI/2023/07/054882
• Lead Sponsor: Dr Baig Mirza Wajeed

Brief Summary

This is a prospective randomized study to compare and assess the effects of intrathecal fentanyl and intrathecal tramadol combined with 0.5% bupivacaine heavy in patients undergoing elective urological surgeries:

1.To evaluate the duration of analgesia of intrathecal bupivacaine 0.5% heavy with tramadol versus intrathecal bupivacaine 0.5% heavy with

fentanyl. 2. To compare hemodynamic changes in both groups. 3. Incidence of side effects if any.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient giving consent to participate in study and scheduled for elective urosurgery.
• Age between 20-60 years ASA grade I and II.

Exclusion Criteria

• Patients not giving consent to participate in the study.
• ASA grade III and IV Patients with respiratory, cardiovascular, hepatic and renal diseases, obesity and pregnancy.
• Age below <20 years and above >60 years.
• Any bleeding disorder and patient on anticoagulants.
• Neurological and musculoskeletal disease.
• Patient already receiving any analgesic.
• Patient already receiving opioid agonist or antagonist in preceding 6 hrs of surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prolonged duration of analgesia with the addition of	from induction of spinal anaesthesia to 6 hrs postoperative period
intrathecal fentanyl.	from induction of spinal anaesthesia to 6 hrs postoperative period
Stable haemodynamic profile with intrathecal tramadol.	from induction of spinal anaesthesia to 6 hrs postoperative period

Secondary Outcome Measures

Name	Time	Method
Lesser side effects with intrathecal tramadol.	from induction of spinal anaesthesia to 6 hrs postoperative period

Trial Locations

Locations (1)

Jayarogya Hospital; 🇮🇳 Gwalior, MADHYA PRADESH, India

Jayarogya Hospital

🇮🇳Gwalior, MADHYA PRADESH, India

Dr Baig Mirza Wajeed

Principal investigator

9423467930

wajeed717@gmail.com