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OpenTrials
Completed

NCT Number: NCT05892705

Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

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

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Key information

Conditions

Intrathecal Dexmedetomidine

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Abbasia, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Injection [Precedex]

Drug

intrathecal injection of 5 mcg dexmedetomidine

Primary outcomes

  1. Effect of subarachnoid dexmedetomidine on hemodynamic parameters.

    Time frame: Two hours

    Measure heart rate, blood pressure, temperature, oxygen saturation

Secondary outcomes

  1. Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.

    Time frame: Six hours

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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