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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intrathecal dexamethasone
Intrathecal dexmedetomidine
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    dexamethasone intrathecal

    dexmedetomidine intrathecal

    Arm Description

    Outcomes

    Primary Outcome Measures

    analgesic effect
    Duration of sensory block and time to first analgesic rescue . .

    Secondary Outcome Measures

    intraoperative complications
    Incidince of intraoperative shivering, nausea and vometing

    Full Information

    First Posted
    January 4, 2021
    Last Updated
    January 5, 2021
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04697745
    Brief Title
    Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections
    Official Title
    Comparison Between Analgesic Effect of Dexamethasone and Dexmedetomidine as an Adjuvant to Bupivacaine for Spinal Anesthesia for Elective Caesarean Sections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    May 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    4. Oversight

    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

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dexamethasone intrathecal
    Arm Type
    Active Comparator
    Arm Title
    dexmedetomidine intrathecal
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal dexamethasone
    Intervention Description
    intrathecal adjuvants to bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal dexmedetomidine
    Intervention Description
    intrathecal adjuvants to bupivacaine
    Primary Outcome Measure Information:
    Title
    analgesic effect
    Description
    Duration of sensory block and time to first analgesic rescue . .
    Time Frame
    Up to 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    intraoperative complications
    Description
    Incidince of intraoperative shivering, nausea and vometing
    Time Frame
    during surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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