Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

NCT05892705 | Completed Phase 4

• 1 other identifier: FAMSU R 120 / 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Intrathecal Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Effect of subarachnoid dexmedetomidine on hemodynamic parameters.

  Measure heart rate, blood pressure, temperature, oxygen saturation

  Two hours

Secondary Outcomes (1)

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

  Six hours

Study Arms (2)

Study drug (dexmedetomidine intrathecal)

ACTIVE COMPARATOR

5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Drug: Dexmedetomidine Injection [Precedex]

Control (saline)

PLACEBO COMPARATOR

0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex] DRUG

intrathecal injection of 5 mcg dexmedetomidine

Control (saline); Study drug (dexmedetomidine intrathecal)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Emergency LSCS.
• Patient refusal enrollment in the study.
• Allergy to the medications.
• Coagulopathy or anticoagulation drugs.
• Fetal or Maternal comorbidities.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 7, 2023
• Study Start: June 1, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)