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Clinical Trials/CTRI/2024/06/069444
CTRI/2024/06/069444Not yet recruitingPhase 4

Comparison of incidence of hypotension in height adjusted dose vs fixed dose of bupivacaine in spinal anesthesia in cesarean section: A randomised controlled trial

Dr SN medical college Jodhpur1 site in 1 country50 target enrollmentStarted: July 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Incidence of hypotension in height adjusted dose of 0.5% heavy bupivacaine (0.06mg/cm) in cesarean section under spinal anaesthesia compared to fixed dose 2ml(10mg) 0.5% heavy bupivacaine in cesarean section under spinal anaesthesia in control group

Study Overview

Brief Summary

The aim of this study is to compare incidence of hypotension in one group receiving height adjusted dose of heavy bupivacaine 0.5%(0.06mg/cm) with other group receiving fixed dose of heavy bupivacaine 0.5% in parturients for cesarean section under spinal anaesthesia.

Following is also compared in each group:

Incidence of nausea and vomiting

Intraoperative fluid requirement

Cumulative dose of vasopressor used

Extent of surgical anaesthesia

Other complications if any (bradycardia,dyspnea)

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Age more than 18 yrs ASA1,2 Elective cesarean section Singleton pregnancy more than 37weeks Uncomplicated pregnancy.

Exclusion Criteria

  • Presenting with any systemic illness Emergent surgery and labouring parturients Multiple or twin pregnancy.

Outcomes

Primary Outcomes

Incidence of hypotension in height adjusted dose of 0.5% heavy bupivacaine (0.06mg/cm) in cesarean section under spinal anaesthesia compared to fixed dose 2ml(10mg) 0.5% heavy bupivacaine in cesarean section under spinal anaesthesia in control group

Time Frame: Blood pressure reading will be monitored once before spinal anaesthesia then after spinal anaesthesia every 1 min for 10 mins, every 5mins till 30 mins then every 10 mins till end of surgery.

Secondary Outcomes

  • Incidence of nausea and vomiting in each group(After spinal anaesthesia till end of surgery)
  • Intraoperative fluid requirement(After spinal anaesthesia till end of surgery)
  • Cumulative dose of vasopressor(ephedrine) required(After spinal anaesthesia till the end of surgery)
  • Extent of surgical anaesthesia in each group(Time to achieve T6 level of sensory block and highest level of sensory block will be noted after administration of drug.)
  • Other complications if any(After intrathecal drug administration in each group)

Investigators

Sponsor
Dr SN medical college Jodhpur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Pratima

Dr SN Medical college, Jodhpur

Study Sites (1)

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