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Clinical Trials/NCT04464616
NCT04464616
Completed
Not Applicable

The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section

Tanta University1 site in 1 country90 target enrollmentJuly 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Tanta University
Enrollment
90
Locations
1
Primary Endpoint
time for the first request of rescue analgesia
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.

Detailed Description

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal analgesia have been proposed. A meta-analysis by Popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects. Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C- fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. Recent studies reported no complications associated with intrathecal dexamethasone. Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al., in their meta-analysis showed that addition of intrathecal DEX significantly increased the duration of postoperative analgesia and reduced analgesic consumption. The increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
January 20, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

tarek abdel hay mostafa

principle investigator

Tanta University

Eligibility Criteria

Inclusion Criteria

  • 90 parturient
  • the statue of American Society of Anesthesiologists' physical class II
  • prepared for an elective cesarean section.

Exclusion Criteria

  • BMI \> 35kg/m2
  • gestational age \< 28 weeks
  • diabetes or gestational diabetes
  • hypertension or pre-eclampsia
  • contraindications to spinal anesthesia
  • height less than 160 Cm
  • history of psychiatric disease
  • taking α-receptor antagonist drugs -a history of allergy to the study drugs-
  • excessive hemorrhage needing transfusion.

Outcomes

Primary Outcomes

time for the first request of rescue analgesia

Time Frame: postoperative first day

time for the first request of rescue morphine analgesia at dose of 3 mg

Secondary Outcomes

  • Neonatal outcome(time of delivery of fetus)
  • Numerical Rating Scale(postoperative first day)
  • Maternal satisfaction(postoperative first day)

Study Sites (1)

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