NCT07520695

Brief Summary

Background: Geriatric patients undergoing femoral neck of fracture (FNOF) repair are highly susceptible to spinal anesthesia-induced hypotension. This study examines whether a two-minute delayed supine position after spinal injection reduces this risk. Methods: Ninety patients aged ≥65 years undergoing FNOF surgery under spinal anesthesia were randomized into two groups. Group D remained seated for two minutes post-spinal injection; Group I was positioned supine immediately. Hemo-dynamic parameters, recorded as primary outcomes, other parameters like vasopressor use, maximum sensory level achieved, duration of surgery, and fluid administration as secondary outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 16, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

supine, post-spinal, geriatric, delayed

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension after spinal anesthesia in both groups

    Hypotension is defined by systolic blood pressure below 90 mmHg or mean arterial BP less than 25% of the basal

    Postprocedural for 2 hours

Study Arms (2)

putting patients immediately in a supine position after spinal anesthesia

ACTIVE COMPARATOR
Procedure: immediate supine position

keeping the patient 2 minutes setting after spinal anesthesia

EXPERIMENTAL
Procedure: 2 minutes setting post spinal anesthesia

Interventions

we put patient in supine position after given spinal immediately

putting patients immediately in a supine position after spinal anesthesia

impact of keeping the patient setting 2 minutes after spinal anesthesia on blood pressure in geriatric patients

keeping the patient 2 minutes setting after spinal anesthesia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Contraindications to spinal anesthesia (e.g., coagulopathy, local infection, etc.).
  • Haemodynamic instability or baseline systolic BP \< 90 mmHg.
  • Allergy to study medications.
  • ASA 4.
  • Morbidly obese patients (BMI\>40).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohar Hospital

Sohar, Oman

Location

MeSH Terms

Conditions

Deception

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant prof

Study Record Dates

First Submitted

March 16, 2026

First Posted

April 9, 2026

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations