Clinical trial NCT04358367: Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia
Official title: Intravenous Dexmedetomidine Reduces Hypotension and Epigastric Pain in Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section Complications
Keywords: dexmedetomidine
spinal anesthesia
cesarean section
epigastric pain
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2020-04-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

Detailed description: Background and aim: Hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The present randomized study aimed to evaluate the effect of intravenous DEX administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section.

Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia and placebo (saline). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes.

Eligibility criteria: Inclusion Criteria:

* Full-term pregnancy and American Society of Anesthesiologists (ASA) physical status I/II in women scheduled for elective cesarean section

Exclusion Criteria:

* Severe hepatic or renal disease
* Severe cardiopulmonary disease
* Thyroid disorders multiple allergies prematurity
* Known fatal abnormality
* Known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.

Primary outcomes:
measure: hypotension
timeFrame: up to 48 hours postoperative
measure: ephedrine use
timeFrame: up to 48 hours postoperative
measure: sedation
timeFrame: up to 48 hours postoperative
measure: epigastric pain
timeFrame: up to 48 hours postoperative
Secondary outcomes:
measure: sensory and motor blocks
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University Faculty of Medicine
Study officials:
affiliation: Al-Azhar University
name: Ahmed Elsawy, MD
role: PRINCIPAL_INVESTIGATOR
References: