NCT07416084

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Feb 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

January 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 30, 2026

Last Update Submit

February 16, 2026

Conditions

Hypotension After Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Maternal hypotension

    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 Outcomes (6)

  • Maternal heart rate trend

    Baseline

  • Use of vasopressors

    Baseline

  • Nausea and vomiting

    Baseline

  • APGAR score

    Baseline

  • Conversion to general anesthesia

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Hyperbaric bupivacaine

ACTIVE COMPARATOR

Hyperbaric bupivacaine used for spinal anesthesia

Drug: Spinal anesthesia with hyperbaric bupivacaine

Isobaric bupivacaine

ACTIVE COMPARATOR

Isobaric bupivacaine used for spinal anesthesia

Drug: Spinal anesthesia with isobaric bupivacaine

Interventions

Spinal anesthesia with hyperbaric bupivacaineDRUG

Spinal anesthesia with hyperbaric bupivacaine according to height

Hyperbaric bupivacaine
Spinal anesthesia with isobaric bupivacaineDRUG

Spinal anesthesia with Isobaric bupivacaine according to height

Isobaric bupivacaine

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital and Medical College

Karachi, Sindh, 75300, Pakistan

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Anum Fatima, MBBS

CONTACT

+923341891863anumrizvi98@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 17, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)