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Completed

NCT Number: NCT07549152

Hemodynamic Effects of Lithotomy Position in Surgical Patients (PH-LITHO)

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

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University Faculty of Medicine

Trabzon, Kalkınma, 61100, Turkey (Türkiye)

About this study

This prospective, randomized clinical study was conducted at Karadeniz Technical University Faculty of Medicine after receiving ethics committee approval (Protocol No: 2021/268)

  • The study included 60 patients aged 65-80, classified as ASA II-III, who had been diagnosed with hypertension and on stable medication for at least 6 months

Randomization and Blinding: Participants were randomized into two groups (n=30 each) using computer-based random number generation

  • Allocation was concealed using sequentially numbered envelopes
  • Researchers involved in data recording and statistical analysis were blinded to the group assignments

Anesthesia Protocol: All patients received standard monitoring (ECG, SpO₂, and non-invasive blood pressure) and were sedated with intravenous midazolam (0.05 mg/kg) and fentanyl (1 µg/kg)

  • Following a 3-minute rest in the supine position, Group L patients were moved to the lithotomy position for 120 seconds before induction, while Group S remained in the supine position
  • Anesthesia was induced with 3-5 mg/kg thiopental administered over 120 seconds
  • A laryngeal mask airway (LMA) was inserted at the 60th second post-induction
  • Maintenance of anesthesia was achieved with desflurane (BIS target: 40-60) and remifentanil infusion

Hemodynamic Monitoring and Intervention: Non-invasive blood pressure (NIBP) was measured immediately after induction (Minute 0) and every minute thereafter for the first 5 minutes

  • Post-induction hypotension (PIH) was defined as a Mean Arterial Pressure (MAP) falling below 65 mmHg or a decrease of more than 20% from the baseline value
  • In the event of hypotension, 5 mg of intravenous ephedrine was administered as a rescue medication

Statistical Analysis: Sample size was calculated based on a 20% expected difference in PIH incidence, requiring 27 patients per group for 95% power

. Statistical analyses were performed using IBM SPSS v23.0, including t-tests, Mann-Whitney U tests, and Kaplan-Meier analysis for time-to-event (onset of hypotension)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pre-induction Lithotomy Position

Other

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

Standard Supine Position

Other

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

Other names: Supine Position, Group S

Primary outcomes

  1. Incidence of Post-induction Hypotension (PIH)

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

    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

Secondary outcomes

  1. Time to Onset of First Hypotension

    Time frame: Within the first 5 minutes after anesthesia induction

    The time elapsed from the completion of anesthesia induction until the first occurrence of hypotension (defined as MAP < 65 mmHg or >20% drop from baseline)

    • This measure evaluates the hemodynamic stability duration provided by the positioning

Sponsors and collaborators

Lead sponsor

Trabzon Karadeniz Teknik Universitesi

Other

Registry information

Official study title

Does the Pre-induction Lithotomy Position Reduce Post-induction Hypotension in Geriatric Hypertensive Patients? A Prospective Randomized Study

Acronym: PIH-LITHO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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