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Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Phase 4
Completed
Conditions
Intrathecal Dexmedetomidine
Interventions
Registration Number
NCT05892705
Lead Sponsor
Ain Shams University
Brief Summary

Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.

Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.

Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.

Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Medically free pregnant Female from 18 to 30 yrs old.
  • Undergoing elective LSCS.
  • Body mass index less than 40.
  • Consenting for sub arachnoid anesthesia.
  • Coagulation profile is within normal ranges.
Exclusion Criteria
  • Emergency LSCS.
  • Patient refusal enrollment in the study.
  • Allergy to the medications.
  • Coagulopathy or anticoagulation drugs.
  • Fetal or Maternal comorbidities.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control (saline)Dexmedetomidine Injection [Precedex]0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Study drug (dexmedetomidine intrathecal)Dexmedetomidine Injection [Precedex]5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Primary Outcome Measures
NameTimeMethod
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.Two hours

Measure heart rate, blood pressure, temperature, oxygen saturation

Secondary Outcome Measures
NameTimeMethod
Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.Six hours

Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.

Trial Locations

Locations (1)

Ain Shams University

🇪🇬

Cairo, Abbasia, Egypt

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