Epidural Anesthesia for Gynecological Surgeries

NCT04174872 | Completed Phase 4 DMC

• 1 other identifier: ME-2001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Analgesics for Comparison

Outcome Measures

Primary Outcomes (1)

• Onset of sensory blockade

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

  Eight months

Study Arms (2)

Dexmedetomidine

OTHER

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.

Drug: Dexmedetomidine; Drug: Midazolam

Midazolam

OTHER

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.

Drug: Dexmedetomidine; Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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.

Also known as: precedex

Dexmedetomidine; Midazolam

Midazolam DRUG

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.

Dexmedetomidine; Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 22, 2019
• Study Start: December 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

EG (1)