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Clinical Trials/CTRI/2024/11/077026
CTRI/2024/11/077026
Not yet recruiting
Phase 4

Effect of intrathecal dexmedetomidine (3µg vs 5µg) as an adjuvant to hyperbaric ropivacaine in cesarean section: A randomized double blind clinical study

Government Medical College Baroda1 site in 1 country126 target enrollmentStarted: November 29, 2024Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Government Medical College Baroda
Enrollment
126
Locations
1
Primary Endpoint
1.Monitoring of spinal characteristics (sensory and motor blockade, satisfaction of spinal anesthesia, visceral traction response, the quality of abdominal muscle relaxation and shivering & sedation score)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

We first determined whether dexmedetomidine combined with intrathecal hyperbaric ropivacaine could improve Hemodynamic stability during cesarean section with block characteristics and prolong postoperative sensory block with no effect on the motor block. Then, we determined which dose of dexmedetomidine was better.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •1.Age Group – 18 years to 40 years 2.ASA – I/II 3.Elective Caesarean section.

Exclusion Criteria

  • •1.Patients Refusal 2.Multifetal pregnancy 3.Heart block & ventricular dysfunction 4.Patient on anticoagulant therapy 5.Patient with local site infection 6.Patients with allergy to study drugs 7.Fetal distress in utero.
  • •8.Severe hypovolemia.
  • •9.Severe operative blood loss expected.
  • •(Placenta Previa, Accrete etc.) 10.Height less than or equal to 150cm.

Outcomes

Primary Outcomes

1.Monitoring of spinal characteristics (sensory and motor blockade, satisfaction of spinal anesthesia, visceral traction response, the quality of abdominal muscle relaxation and shivering & sedation score)

Time Frame: Till 24hrs

2.Hemodynamic stability (intraoperative)

Time Frame: Till 24hrs

Secondary Outcomes

  • 1.Postoperative analgesia score (VAS SCORE)(2. Apgar score of neonates)

Investigators

Sponsor
Government Medical College Baroda
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Praveen Rathod

Government Medical College Baroda

Study Sites (1)

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