NCT07549152

Brief Summary

Anesthesia-induced hypotension is a common occurrence in elderly hypertensive patients and is closely associated with increased postoperative morbidity

  • This study aims to investigate whether the lithotomy position, a non-pharmacological and cost-free approach, can reduce the incidence of post-induction hypotension (PIH) in this high-risk population by increasing venous return Sixty patients aged 65-80 with a history of hypertension were randomly assigned to either the Supine Group (Group S) or the Lithotomy Group (Group L)
  • In Group L, patients were placed in the lithotomy position 120 seconds before the start of anesthesia induction
  • Blood pressure was monitored every minute for the first five minutes following induction
  • The study evaluates whether this simple positioning strategy can maintain hemodynamic stability, reduce the drop in mean arterial pressure, and decrease the overall need for vasopressor medications like ephedrine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 17, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Lithotomy positionAnesthesia InductionHemodynamic stabilityPatient PositioningGeriatricGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Post-induction Hypotension (PIH)

    Post-induction hypotension is defined as a Mean Arterial Pressure (MAP) falling below 65 mmHg or a decrease of more than 20% from the baseline value

    Within the first 5 minutes following the completion of anesthesia induction (measurements recorded at minutes 0, 1, 2, 3, 4, and 5)

Secondary Outcomes (1)

  • Time to Onset of First Hypotension

    Within the first 5 minutes after anesthesia induction

Study Arms (2)

Group S (Supine Position Group)

ACTIVE COMPARATOR

Patients in this group undergo anesthesia induction in the standard supine position

Other: Standard Supine Position

Group L (Lithotomy Position Group

EXPERIMENTAL

Patients in this group are placed in the lithotomy position before the start of anesthesia induction to evaluate its effect on hemodynamic stability

Other: Pre-induction Lithotomy Position

Interventions

Patients are moved to the lithotomy position 120 seconds prior to the start of anesthesia induction to increase venous return * Following this 120-second interval in the lithotomy position, anesthesia is induced with intravenous midazolam (0.05 mg/kg), fentanyl (1 µg/kg), and thiopental (3-5 mg/kg) * All inductions are performed at a constant rate over 120 seconds * Post-induction hypotension (defined as MAP \< 65 mmHg or \>20% drop from baseline) is treated with 5 mg of intravenous ephedrine

Group L (Lithotomy Position Group

Patients remain in the standard supine position for a 3-minute rest period before induction begins * General anesthesia is induced using the same protocol as the experimental group: intravenous midazolam (0.05 mg/kg), fentanyl (1 µg/kg), and thiopental (3-5 mg/kg) administered over a period of 120 seconds * Hypotension (defined as MAP \< 65 mmHg or \>20% drop from baseline) is managed with 5 mg of intravenous ephedrine as rescue therapy

Also known as: Supine Position, Group S
Group S (Supine Position Group)

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65 and 80 years.
  • American Society of Anesthesiologists (ASA) physical status class II or III.
  • Clinical diagnosis of hypertension.
  • Continuous use of the same antihypertensive medication for at least 6 months.
  • Scheduled for elective surgery requiring the lithotomy position.

You may not qualify if:

  • Uncontrolled hypertension.
  • Arrhythmias requiring medical treatment.
  • Left ventricular ejection fraction (LVEF) \< 40%.
  • Unstable ischemic heart disease.
  • Physical inability to be placed in the lithotomy position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Medicine

Trabzon, Kalkınma, 61100, Turkey (Türkiye)

Location

Related Publications (5)

  • Miyabe M, Sonoda H, Namiki A. The effect of lithotomy position on arterial blood pressure after spinal anesthesia. Anesth Analg. 1995 Jul;81(1):96-8. doi: 10.1097/00000539-199507000-00019.

    PMID: 7598290BACKGROUND
  • Kweon TD, Jung CW, Park JW, Jeon YS, Bahk JH. Hemodynamic effect of full flexion of the hips and knees in the supine position: a comparison with straight leg raising. Korean J Anesthesiol. 2012 Apr;62(4):317-21. doi: 10.4097/kjae.2012.62.4.317. Epub 2012 Apr 23.

    PMID: 22558496BACKGROUND
  • Fakhari S, Bilehjani E, Farzin H, Pourfathi H, Chalabianlou M. The effect of passive leg-raising maneuver on hemodynamic stability during anesthesia induction for adult cardiac surgery. Integr Blood Press Control. 2018 Jun 7;11:57-63. doi: 10.2147/IBPC.S126514. eCollection 2018.

    PMID: 29922085BACKGROUND
  • Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.

    PMID: 16115962BACKGROUND
  • Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.

    PMID: 28974066BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researchers involved in hemodynamic data recording and statistical analysis were blinded to the group assignments
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Anesthesiology and Reanimatio

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

March 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to maintain patient confidentiality and as per institutional policy

Locations