Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07549152
Acronym
PIH-LITHO
Enrollment
60
Registered
2026-04-23
Start date
2021-03-01
Completion date
2022-01-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric Anesthesia, Hypertension (HTN), Post-induction Hypotension (PIH)

Keywords

Lithotomy position, Anesthesia Induction, Hemodynamic stability, Patient Positioning, Geriatric, General Anesthesia

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

Detailed description

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)

Interventions

OTHERPre-induction Lithotomy Position

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

OTHERStandard Supine Position

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

Sponsors

Trabzon Karadeniz Teknik Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Researchers involved in hemodynamic data recording and statistical analysis were blinded to the group assignments

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post-induction Hypotension (PIH)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

MeasureTime frameDescription
Time to Onset of First HypotensionWithin the first 5 minutes after anesthesia inductionThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026