Post-induction Hypotension (PIH)PIH-LITHONCT07549152
Hemodynamic Effects of Lithotomy Position in Surgical Patients (PH-LITHO)
A study testing Pre-induction Lithotomy Position and Standard Supine Position in people with Post-induction Hypotension (PIH) and Hypertension (HTN), run by Trabzon Karadeniz Teknik Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Post-induction Hypotension (PIH), Hypertension (HTN), Geriatric Anesthesia
- What is being tested?
- Pre-induction Lithotomy Position and Standard Supine Position
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 31 Jan 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Medicine
Trabzon, Kalkınma, 61100
About this study
Official title: Does the Pre-induction Lithotomy Position Reduce Post-induction Hypotension in Geriatric Hypertensive Patients? A Prospective Randomized Study
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
Read more
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
Read the 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)
- Being tested
- Pre-induction Lithotomy Position, Standard Supine Position
- Keywords
- Lithotomy position, Anesthesia Induction, Hemodynamic stability, Patient Positioning, Geriatric, General Anesthesia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-induction Lithotomy PositionOther
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 PositionOther
Also called Supine Position, Group S
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
| Study group | Role | What they receive |
|---|---|---|
| Group S (Supine Position Group) | Active comparator | Patients in this group undergo anesthesia induction in the standard supine position Receives: 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 Receives: Other: Pre-induction Lithotomy Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Within the first 5 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Mar 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-induction Hypotension (PIH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Karadeniz Teknik Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samet Kandemir, Trabzon Karadeniz Teknik Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549152
- Sponsor's protocol ID
- KTU-PIH-2021
- Other IDs
- Karadeniz Technical University
- Acronym
- PIH-LITHO
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to maintain patient confidentiality and as per institutional policy
Publications
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.
PubMed 7598290Kweon 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.
PubMed 22558496Fakhari 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.
PubMed 29922085Reich 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.
PubMed 16115962Sudfeld 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.
PubMed 28974066