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

Phase 2

Completed

• Conditions: Cesarean Section; Spinal Anesthesia; Dexmedetomidine
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03775655
• Lead Sponsor: Menoufia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Status Verified: 2019-01
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LD-DEX	Dexmedetomidine	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Menoufia University Hospitals; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt