Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Phase 4

Completed

• Conditions: Intrathecal Dexmedetomidine
• Interventions: Drug: Dexmedetomidine Injection [Precedex]

• 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

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-05
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-28
• Last Update Submitted: 2023-05-28
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07

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

Group	Intervention	Description
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

Name	Time	Method
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.	Two hours	Measure heart rate, blood pressure, temperature, oxygen saturation

Secondary Outcome Measures

Name	Time	Method
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