Comparison of effect of Intravenous Fentanyl vs Intravenous Dexmedetomidine on Characteristics of Spinal Anaesthesia

Phase 2

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/059118
• Lead Sponsor: Dr Runjhun Jain

Brief Summary

It is a prospective, randomized, double blind, comparitive study. It is to study the effect of intravenous Fentanyl ( 1 mcg/kg ) vs intravenous Dexmedetomidine ( 0.5 mcg/kg) on characteristics of spinal anaesthesia to observe and compare the following parameters:

1. Time to achieve sensory blockade at T10

2. Time to achieve complete motor block

3. Highest level of sensory blockade achieved

4. Intraoperative hemodynamic parameters

5. Ramsay sedation score

6. Regression of Spinal Anaesthesia by two segments

7. Time to first rescue analgesia ( Duration of analgesia )

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-11
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

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

Inclusion Criteria

• ASA grade I or II fit patients.
• Ages between 18 and 65 years of either gender.
• Patients posted for infra umbilical surgery under sub-arachnoid block.
• Availability of informed consent.

Exclusion Criteria

• Patients with ASA physical status III or more.
• Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease or with coagulation abnormalities.
• Patients with contraindication for spinal anaesthesia.
• Patients with known allergies to the study drug.
• Patient refusal.
• Patients below 18 years and above 65 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to achieve sensory blockade at T10, Time to achieve complete motor block, Highest level of sensory blockade achieved, Intraoperative hemodynamic parameters, Ramsay sedation score, Regression of spinal anaesthesia by two segments	Basic vital parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, oxygen saturation & Ramsay sedation score will be recorded. Then, these will be recorded after dural puncture & every 5 min for 15 min & then every 15 min interval till the end of surgery after spinal anaesthesia.

Secondary Outcome Measures

Name	Time	Method
Time of requirement of the first dose of postoperative rescue analgesic	1 hour, 2 hour, 4 hour, 8 hour, 12 hour & 24 hour after administration of Sub Arachnoid Block

Trial Locations

Locations (1)

Dr. D. Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dr. D. Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Aparna Bagle

Principal investigator

9422710943

draparnabagle@gmail.com