Comparison of Hypotension After Spinal Anesthesia With Hyperbaric Vs Isobaric Bupivacaine in Elective Cesarean After Colloid Preloading.

February 16, 2026 updated by: Anum Fatima, Liaquat National Hospital & Medical College

Comparison of Maternal Hypotension After Spinal Anesthesia With Hyperbaric Bupivacaine Vs Isobaric Bupivacaine in Elective Cesarean Section With Colloid Preloading

To assess the hemodynamic difference after spinal anesthesia with hyperbaric bupivacaine and isobaric bupivacaine in elective cesarean section

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Liaquat National Hospital and Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA II parturient with normal pregnancy Parturients undergoing elective cesarean section under spinal anesthesia Parturient refusing normal trial of labor, planned for ELLSCS under spinal anesthesia

Exclusion Criteria:

  • Patient refusal Parturient with known drug allergy to local anesthetics Parturients undergoing emergency cesarean section Spinal anesthesia converted to general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyperbaric bupivacaine
Hyperbaric bupivacaine used for spinal anesthesia
Drug: Spinal anesthesia with hyperbaric bupivacaine
Spinal anesthesia with hyperbaric bupivacaine according to height
Active Comparator: Isobaric bupivacaine
Isobaric bupivacaine used for spinal anesthesia
Drug: Spinal anesthesia with isobaric bupivacaine
Spinal anesthesia with Isobaric bupivacaine according to height

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal hypotension
Time Frame: Baseline
Incidence of maternal hypotension (MAP < 60 mm Hg or drop in MAP > 20% of the baseline) within 5 minutes after intrathecal drug administration
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal heart rate trend
Time Frame: Baseline
Maternal heart rate as bpm
Baseline
Use of vasopressors
Time Frame: Baseline
Requirement for vasopressors
Baseline
Nausea and vomiting
Time Frame: Baseline
incidence of nausea/vomiting due to hypotension
Baseline
APGAR score
Time Frame: Baseline
Fetal Apgar scores at 1 and 5 minutes
Baseline
Conversion to general anesthesia
Time Frame: Baseline
Patients requiring general anesthesia after spinal anesthesia
Baseline
Maternal MAP trend
Time Frame: Baseline
MAP as mm Hg
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat National Hospital & Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1327-2026-LNH-ERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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