Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Dow University of Health Sciences

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Drug: Bupivacaine, fentanyl; Drug: Bupivacaine, dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04095013

[e-mail]

Details and patient eligibility

About

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

Full description

The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Term pregnancy Singleton ASA I and II, BMI <35, elective C/section

Exclusion criteria

patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group BF

Experimental group

Description:

hyperbaric Bupivacaine 10mg with fentanyl 10micrograms

Treatment:

Drug: Bupivacaine, fentanyl

Group BD

Experimental group

Description:

hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Treatment:

Drug: Bupivacaine, dexmedetomidine