Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

NCT ID: NCT05892705

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-01-15

Brief Summary

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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

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Conditions

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Intrathecal Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Study drug (dexmedetomidine intrathecal)

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

intrathecal injection of 5 mcg dexmedetomidine

Control (saline)

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

Group Type PLACEBO_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

intrathecal injection of 5 mcg dexmedetomidine

Interventions

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Dexmedetomidine Injection [Precedex]

intrathecal injection of 5 mcg dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohamed Samir Ezzat Rakhia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FAMSU R 120 / 2021

Identifier Type: -

Identifier Source: org_study_id

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