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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775655
• Other study ID #: 9076411
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Dexmedetomidine
• Spinal Anesthesia

Intervention

Drug:
• Dexmedetomidine
10µg dexmedetomidine will be added to the injectate to be injected intrathecally

Locations

Country	Name	City	State
Egypt	Menoufia University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of motor and sensory blockade		Intraoperative
Primary	Haemodynamic stability and total doses of IV fluids and vasopressors		Intraoperative
Primary	Time to first postoperative rescue analgesic request		24 hour
Secondary	The intraoperative patient and surgeon satisfaction (successful delivery)		Intraoperative
Secondary	The peak sensory level of block		Intraoperative
Secondary	Time from intrathecal injection to peak sensory block level		Intraoperative
Secondary	The time to two sensory block segment regression		Intraoperative and 24 hour
Secondary	Degree and duration of motor block		Intraoperative and 24 hour
Secondary	Intraoperative analgesic supplementation during operation		Intraoperative
Secondary	Postoperative pain scores for 24 hours		24 hour
Secondary	Frequency and total dose of postoperative analgesics		24 hour
Secondary	Intraoperative and postoperative sedation scores		Intraoperative and 24 hour
Secondary	Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.		Intraoperative and 24 hour
Secondary	Hospital in stay		24 hour
Secondary	Time to S1 level sensory regression		Intraoperative and 24 hour