NCT07616882

Brief Summary

To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Apr 2027

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

First Submitted

Initial submission to the registry

May 15, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 15, 2026

Last Update Submit

May 26, 2026

Conditions

Hemondynamic Changes in Spinal Anesthesia

Keywords

Spinal ansethesia, Fractionated, Bolus

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Pressure

    Difference in mean arterial pressure between Group B and Group F

    Baseline and up to 120 minutes

Secondary Outcomes (2)

  • Hypotension and bradycardia

    Baseline and up to 120 minutes

  • Requirement of vasopressors

    Baseline and up to 120 minutes

Study Arms (2)

Group B (Bolus)

ACTIVE COMPARATOR

Group B patients will be given a bolus dose of hyperbaric bupivacaine in a bolus fashion mean all of calculated drug will be given in one shot

Drug: Spinal Anesthesia (bupivacaine)

Group F (Fractionated)

ACTIVE COMPARATOR

In group F Spinal Anesthesia will be given as 2/3 of the initial dose will be give and then after 90 seconds remaining 1/3 dose will be given of hyperbaric bupivacaine.

Drug: Spinal Anesthesia (bupivacaine)

Interventions

Spinal Anesthesia (bupivacaine)DRUG

In this group B spinal Anesthesia will be given in one single shot

Group B (Bolus)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I and II
  • Adults 18 to 60 years of age of either gender
  • height from 160 to 182cm and BMI from 15 to 29.9kg/m2

You may not qualify if:

  • ASA III and IV
  • Refusal of consent
  • any known renal, hepatic, cardiac or cerebrovascular disease
  • hypersensitivity to local anaesthetics drug
  • spinal deformity or any contra indications to spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 74000, Pakistan

Location

MeSH Terms

Interventions

Anesthesia, SpinalBupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Usama, MBBS

CONTACT

+923008978791bhurgriusama@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2026

First Posted

June 1, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)