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

NCT03775655 | Completed Phase 2

• 1 other identifier: 9076411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Spinal Anesthesia; Dexmedetomidine

Keywords

Cesarean Section; Intrathecal Dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

Study Arms (2)

LD-DEX

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).

Interventions

Dexmedetomidine DRUG

10μg dexmedetomidine will be added to the injectate to be injected intrathecally

Also known as: Precedex

LD-DEX

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mamdoh Lotfy, Prof. Dr.

  Faculty of Medicine - Menoufia University

  STUDY CHAIR

• Safaa M Helal, Prof. Dr.

  Faculty of Medicine - Menoufia University

  STUDY CHAIR

• Wesameldin A Soltan, Dr.

  Faculty of Medicine - Menoufia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: September 1, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

EG (1)