Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections

January 5, 2021 updated by: Baher Said Elshahat Mohamed Abdelhady, Benha University

Comparison Between Analgesic Effect of Dexamethasone and Dexmedetomidine as an Adjuvant to Bupivacaine for Spinal Anesthesia for Elective Caesarean Sections

The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
  • Elective cesarean section under spinal anaesthesia
  • Gestational age > 37 weeks
  • BMI less than 30 kg/m2

Exclusion Criteria:

  • Patient refusal
  • unable to give consent
  • age < 18 or > 40
  • BMI more than 30 kg/m2
  • known allergy to the study medication
  • coagulopathies or on anticoagulant medications
  • diabetic neuropathy
  • patients with psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexamethasone intrathecal
Drug: Intrathecal dexamethasone
intrathecal adjuvants to bupivacaine
Active Comparator: dexmedetomidine intrathecal
Drug: Intrathecal dexmedetomidine
intrathecal adjuvants to bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic effect
Time Frame: Up to 24 hours after surgery

Duration of sensory block and time to first analgesic rescue .

.
Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative complications
Time Frame: during surgery
Incidince of intraoperative shivering, nausea and vometing
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

May 30, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adjuvant to spinal anesthesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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