Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Intrathecal Dexmedetomidine Clinical Trial

Official title:

Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892705
• Other study ID #: FAMSU R 120 / 2021
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrathecal Dexmedetomidine
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexmedetomidine Injection [Precedex]
intrathecal injection of 5 mcg dexmedetomidine

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of subarachnoid dexmedetomidine on hemodynamic parameters.	Measure heart rate, blood pressure, temperature, oxygen saturation	Two hours
Secondary	Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.	Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.	Six hours