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

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ClinicalTrials.gov Identifier: NCT03775655
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Ashraf Nasr, Menoufia University

Study Description
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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

Study Design
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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

Arms and Interventions
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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%).


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03775655


Locations
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Egypt
Menoufia University Hospitals
Shibīn Al Kawm, Menoufia, Egypt
Sponsors and Collaborators
Menoufia University
Investigators
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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
More Information
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Responsible Party: Ahmed Ashraf Nasr, Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University, Menoufia University
ClinicalTrials.gov 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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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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