Epidural Anesthesia for Gynecological Surgeries

Epidural Analgesics for Comparison Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174872
• Other study ID #: ME-2001
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epidural Analgesics for Comparison

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Surgical ICU, and Pain Management	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of sensory blockade	time interval from epidural injection of drugs to sensory blockade at T10	Eight months