Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial

The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Spinal Anesthesia; Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Menoufia University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Full-term pregnant women
• Singleton gestation
• American Society of Anaesthesiologists (ASA) physical status classes II and I

Exclusion Criteria:

• Preterm pregnancy (<37 wks. gestation)
• Multiple gestation
• Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
• Asthma and allergy to non-steroidal anti-inflammatory drugs
• Conditions that prevent spinal anaesthesia
• Failed spinal block and conversion to general anaesthesia
• A history of established chronic pain
• Drug addiction
• A psychiatric disorder
• Inability to communicate effectively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LD-DEX; This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).	Drug: Dexmedetomidine; 10μg dexmedetomidine will be added to the injectate to be injected intrathecally; Other Names: Precedex
No Intervention: Control group; This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Density of motor and sensory blockade	Intraoperative
Haemodynamic stability and total doses of IV fluids and vasopressors	Intraoperative
Time to first postoperative rescue analgesic request	24 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
The intraoperative patient and surgeon satisfaction (successful delivery)	Intraoperative
The peak sensory level of block	Intraoperative
Time from intrathecal injection to peak sensory block level	Intraoperative
The time to two sensory block segment regression	Intraoperative and 24 hour
Degree and duration of motor block	Intraoperative and 24 hour
Intraoperative analgesic supplementation during operation	Intraoperative
Postoperative pain scores for 24 hours	24 hour
Frequency and total dose of postoperative analgesics	24 hour
Intraoperative and postoperative sedation scores	Intraoperative and 24 hour
Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.	Intraoperative and 24 hour
Hospital in stay	24 hour
Time to S1 level sensory regression	Intraoperative and 24 hour

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Mamdoh Lotfy, Prof. Dr., Faculty of Medicine - Menoufia University; Study Chair: Safaa M Helal, Prof. Dr., Faculty of Medicine - Menoufia University; Study Director: Wesameldin A Soltan, Dr., Faculty of Medicine - Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean Section; Intrathecal Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 9076411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No