comparison of the effects of combination of two drugs used for giving spinal anesthesia for surgeries below the umbilicus.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/051732
• Lead Sponsor: Dr Shruti Desai

Brief Summary

Ours is a prospective randomised observational study.

we will take 180 patients posted for elective infraumbilical surgery of either gender in the age group of 18-60 years with ASA grade I or II. Patients will be randomly divided into two groups of 90 patients each based on closed envelope method.

Group RC: will receive 3 ml of 0.75% hyperbaric ropivacaine + 30 ug of clonidine in 0.5 ml normal saline. Total volume 3.5 ml intrathecally.

Group RD: will receive 3 ml of 0.75% hyperbaric ropivacaine + 5 ug dexmedetomidine in 0.5 ml normal saline. Total volume 3.5 ml intrathecally.

The parameters assessed will be - onset of sensory block, onset of motor block, time to highest sensory level, time to modified Bromage scale 3, time to S2 segment regression, time to modified Bromage scale 0, time to first rescue analgesic and adverse effects like nausea, vomiting, shivering, hypotension, bradycardia.

VAS score will be assessed postoperatively for first 24 hrs.

Intraoperative vitals will be monitored immediately after spinal block, then every 5 mins for the first half hr and then every 30 mins till the end of surgery. Postoperatively the vitals will be monitored immediately postoperatively and then every hourly till 6 hrs and then at 12 hrs and 24 hrs.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-18
• Study Start: 2023-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• ASA grade I and II BMI< 30 kg/m2 Patients who have given written informed consent.
• Patients undergoing elective infraumbilical surgeries under spinal anaesthesia.

Exclusion Criteria

• 1.ASA grade III and IV 2.Patients with known psychiatric illness, chronic pain or any condition that precludes intrathecal anesthesia.
• 3.Patients with deformity of the spine.
• 4.Patients with skin infection at the site of anesthesia.
• 5.Known sensitivity or allergy to the study drugs 6.Patients on chronic anticoagulants or antit platelet drugs or patients with coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the onset and duration of sensory and motor blockade and duration of postoperative analgesia	The effects will be assessed at baseline,5,10,15, 20,25,30,60,90,120,150,180 minutes after giving spinal anesthesia.Postoperatively the analgesia effect will be assessed at baseline, 1,2,3,4,5,6,12 and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
to assess perioperative hemodynamic stability and incidence of side effects	The hemodynamic stobility and adverse effects will be assessed intraoperatively at baseline,5,10,15, 20,25,30,60,90,120,150,180 minutes after giving spinal anesthesia. And Postoperatively it will be assessed at baseline, 1,2,3,4,5,6,12 and 24 hours postoperatively.

Trial Locations

Locations (1)

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

GCS Medical College, Hospital and Research Centre

🇮🇳Ahmadabad, GUJARAT, India

Dr Shruti Desai

Principal investigator

9429525791

shru30791@gmail.com