comparison between 2 drugs in gynecological surgery

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/059020
• Lead Sponsor: DR SOMSUNDAR R G

Brief Summary

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|Spinal anaesthesia will be performed at the level of L3-L4 through a midline approach using a 25-gauge Quincke spinal needle with patient in lateral position. After confirming free flow of cerebrospinal fluid, drug is injected into subarachnoid space.

Patients will be divided into three groups of thirty each (n=30):-

Group BC ,Group BD and Group BS.

Group-BC: 0.5% bupivacaine 17.5mg (3.5ml) with 50µg Clonidine (in 0.5ml normal saline) (Total volume-4ml) .

Group-BD: 0.5% bupivacaine 17.5mg (3.5ml) with 5 µg Dexmedetomidine

(in 0.5ml  normal saline) (Total volume-4ml).

Group-BS:0.5% Bupivacaine 17.5mg (3.5ml) with 0.9% Normal saline (0.5ml)

(Total volume-4 ml).

The time to reach T6 dermatome sensory block will berecorded before surgery.Visual Analog Scale will be recorded up to 24 hoursto assess adequacy of analgesia

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-21
• Study Start: 2023-11-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 1.Patients who are posted for elective gynecological surgeries.
• 2.Age group 18-60 years.
• 3.American Society of Anesthesiologists (ASA) grades I and II.
• 4.Patients with Body Mass Index (BMI) between 18.5-24.9. 5.Patients with height ranging between 150 cm and 180 cm .
• 6.Patients who are willing to participate in the study with informed consent.

Exclusion Criteria

1.Patients taking alpha-adrenergic receptor antagonists, calcium channel blockers and angiotensin converting enzyme inhibitors 2.Patients having any absolute contraindications for spinal anaesthesia like increased intracranial tension, severe hypovolemia, history of bleeding diathesis and local infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect and adverse effect of intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as adjuvants to 0.5% Hyperbaric Bupivacaine in subarachnoid block in patients undergoing elective gynaecological surgeries by using the following parameters:	BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN
1. Duration of analgesia.	BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN
2. To assess the onset and duration of motor block.	BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN

Secondary Outcome Measures

Name	Time	Method
Peri-operative hemodynamic changes and adverse effects	2 HOURS , 8 HOURS , 12 HOURS , 24 HOURS

Trial Locations

Locations (1)

Mims , Mandya; 🇮🇳 Mandya, KARNATAKA, India

Mims , Mandya

🇮🇳Mandya, KARNATAKA, India

DR Sharmila Sherin

Principal investigator

9483921926

drsharmilasherin@gmail.com