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Clinical Trials/NCT04174872
NCT04174872
Completed
Phase 4

A Comparative Study Between Dexmedetomidine and Midazolam as Adjuvant to Bupivacaine During Epidural Anesthesia For Elective Gynecological Operations

Cairo University1 site in 1 country150 target enrollmentDecember 1, 2019

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Epidural Analgesics for Comparison
Sponsor
Cairo University
Enrollment
150
Locations
1
Primary Endpoint
Onset of sensory blockade
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit (ICU) patients as it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration of preservative free midazolam induces antinociceptive effects in humans, when midazolam is added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal delta receptors so antinociceptive effects of morphine like substances are potentiated when epidural midazolam is added. Studies have revealed that use of epidural midazolam provides effective analgesia in adults. So, the present study will evaluate the additive analgesic effects of epidural midazolam in combination with bupivacaine in elective gynecologic surgeries and compare the results with the use of bupivacaine with dexmedetomidine and observe the quality of epidural anesthesia with occurrence of side effects.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
June 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reham Ali Abdelhaleem Abdelrahman

Lecturer of Anesthesia

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Female patients of ASA I-II.
  • Aged 18-55 years undergoing elective gynecological surgeries

Exclusion Criteria

  • Patient refusal.
  • Patients with history of diabetes mellitus, cardiac disease, hypertension, chronic obstructive respiratory disease, coagulation abnormalities, spinal deformities, patients allergic to amide type of local anesthetics, localized skin sepsis, neurological disease, hepatic and renal diseases, peripheral neuropathy and psychiatric diseases.

Arms & Interventions

Dexmedetomidine

It has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.

Intervention: Dexmedetomidine

Dexmedetomidine

It has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.

Intervention: Midazolam

Midazolam

Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.

Intervention: Dexmedetomidine

Midazolam

Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.

Intervention: Midazolam

Outcomes

Primary Outcomes

Onset of sensory blockade

Time Frame: Eight months

time interval from epidural injection of drugs to sensory blockade at T10

Study Sites (1)

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