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

NCT ID: NCT04095013

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomize controlled trial (RCT)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Patients were randomly allocated into two groups and will be blinded to the study drugs. The drugs will be chosen by seal envelope method by principal investigator and co-investigator. The drugs will be filled in the syringes and the syringes handed over to on floor consultant anesthetist who are blinded to the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group BF

hyperbaric Bupivacaine 10mg with fentanyl 10micrograms

Group Type EXPERIMENTAL

Bupivacaine, fentanyl

Intervention Type DRUG

Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,

Group BD

hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Group Type EXPERIMENTAL

Bupivacaine, dexmedetomidine

Intervention Type DRUG

Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine, fentanyl

Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,

Intervention Type DRUG

Bupivacaine, dexmedetomidine

Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sana Urooj

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Civil Hospital Karachi

Karachi, Sindh, Pakistan

Site Status

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

[email protected]

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine for Cesarean Delivery
NCT01005433 COMPLETED PHASE1