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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03775655
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
Ahmed Ashraf Nasr, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Spinal Anesthesia Dexmedetomidine Drug: Dexmedetomidine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: Precedex

No Intervention: Control group
This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).

Primary Outcome Measures :
  1. Density of motor and sensory blockade [ Time Frame: Intraoperative ]
  2. Haemodynamic stability and total doses of IV fluids and vasopressors [ Time Frame: Intraoperative ]
  3. Time to first postoperative rescue analgesic request [ Time Frame: 24 hour ]

Secondary Outcome Measures :
  1. The intraoperative patient and surgeon satisfaction (successful delivery) [ Time Frame: Intraoperative ]
  2. The peak sensory level of block [ Time Frame: Intraoperative ]
  3. Time from intrathecal injection to peak sensory block level [ Time Frame: Intraoperative ]
  4. The time to two sensory block segment regression [ Time Frame: Intraoperative and 24 hour ]
  5. Degree and duration of motor block [ Time Frame: Intraoperative and 24 hour ]
  6. Intraoperative analgesic supplementation during operation [ Time Frame: Intraoperative ]
  7. Postoperative pain scores for 24 hours [ Time Frame: 24 hour ]
  8. Frequency and total dose of postoperative analgesics [ Time Frame: 24 hour ]
  9. Intraoperative and postoperative sedation scores [ Time Frame: Intraoperative and 24 hour ]
  10. Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation. [ Time Frame: Intraoperative and 24 hour ]
  11. Hospital in stay [ Time Frame: 24 hour ]
  12. Time to S1 level sensory regression [ Time Frame: Intraoperative and 24 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03775655

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Menoufia University Hospitals
Shibīn Al Kawm, Menoufia, Egypt
Sponsors and Collaborators
Menoufia University
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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
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Responsible Party: Ahmed Ashraf Nasr, Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University, Menoufia University Identifier: NCT03775655    
Other Study ID Numbers: 9076411
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Ashraf Nasr, Menoufia University:
Cesarean Section
Intrathecal Dexmedetomidine
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action