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Laparoscopic SurgeryNCT06669689

The Impact of Anesthesia and Positioning on Cerebral Blood Flow and Pressure in Patients Undergoing Laparoscopic Surgery

An observational study of Laparoscopic Surgery, run by Xiaguang Duan at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this observational study was to understand the effect of ReverseTrendelenburg position, Trendelenburg position on intracranial pressure and carotid blood flow in patients undergoing laparoscopic surgery. Read more about this study

Who is it for?
Ages 29 to 62 years, women only
Conditions the study is for
Laparoscopic Surgery
What is being tested?
operating position and pneumoperitoneum
Type of treatment
Medical device
How many people
60 participants
Where
1 siteChina
Study dates
1 Feb 2023to 30 Dec 2023
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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 29 to 62 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia.

Who may be able to join

  • agreed to participate and signed informed consent forms
  • classified as ASA I-II adults

Who cannot join

  • allergy to anesthetics
  • refused to sign the consent form or were uncooperative
  • a body mass index (BMI) ≥30 kg m-2
  • uncontrolled hypertension
  • uncontrolled diabetes
  • cirrhosis or renal impairment
  • cardiopulmonary insufficiency
  • persistent eye infections, or a history of ophthalmic surgery

Trial locations and contacts

1 site in 1 country.

China1 site
  • Inner Mongolia Baogang Hospital

    Baotou, Inner Mongolia, 014010

Other trials in China

About this study

Official title: The Impact of Anesthesia and Positioning on Cerebral Blood Flow and Pressure in Patients Undergoing Laparoscopic Surgery: an Observational Study

The aim of this observational study was to understand the effect of ReverseTrendelenburg position, Trendelenburg position on intracranial pressure and carotid blood flow in patients undergoing laparoscopic surgery. The main question it aims to answer is:

Does ReverseTrendelenburg position increase common carotid artery (CCA) flow, optic nerve sheath diameter (ONSD); does Trendelenburg position decrease CCA flow, ONSD.

Read the detailed description

This study was approved by the Medical Ethics Committee of Inner Mongolia Baogang Hospital, on January 11, 2023 (2023-MER-26),follow the Declaration of Helsinki. All participants voluntarily agreed to participate and signed informed consent forms. Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia. Patients were excluded if they had an allergy to anesthetics used in this study or experienced adverse reactions to analgesics included in the study. Patients were deemed ineligible for clinical evaluation if they refused to sign the consent form or were uncooperative. We excluded patients with a body mass index (BMI) ≥30 kg m-2, uncontrolled hypertension, uncontrolled diabetes, cirrhosis or renal impairment, cardiopulmonary insufficiency, cerebrovascular disease, glaucoma, persistent eye infections, or a history of ophthalmic surgery.

Upon entering the operating room, patients were monitored for pulse oximetry, ECG, BIS, and non-invasive arterial blood pressure. Prior to surgery, patients were administered Penehyclidine Hydrochloride Injection (Lot H20051948, Chengdu List Pharmaceutical Co., Ltd., China) at a dose of 0.01 mg kg-1i.v.. Patients were induced with propofol (1.5-2 mg kg-1i.v.), rocuronium (1-2 mg kg-1i.v.), and fentanyl (1-2μg kg-1i.v.). Anesthesia was maintained with inhaled sevoflurane or desflurane, with inhalation concentrations adjusted according to BIS. Remifentanil (0.05-0.2μg kg-1 min-1i.v.) was continuously infused, with blood pressure and heart rate adjusted to ±20% of baseline values. After induction, patients were mechanically ventilated using the Pressure-Regulated Volume Control (PRVC) mode. Ventilator parameters were set as tidal volume 6-8 ml kg-1, PEEP 0 cmH2O, I ratio of 1:2, respiratory rate 16 breaths per minute (BPM), and FiO2 of 41%. In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°. Pneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg.

Measurements were recorded at five time points: before anesthesia (T1), after intubation (T2), after position change (Trendelenburg or Reverse Trendelenburg position) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5)( Fig 1 b). Parameters measured included mean arterial pressure (MAP; calculated as diastolic pressure + 1/3 pulse pressure), heart rate (HR), Bispectral Index (BIS), PIP, end-tidal carbon dioxide (ETCO2), tidal volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD). CCA flow, CCA beat volume, CCA diameter, and ONSD were measured using ultrasound by a trained researcher. Ultrasound measurements were performed using the LOGIQ™ E20 device (GE Healthcare, Chicago, Illinois, USA) equipped with a linear 7.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) and a 2.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) to assess optic nerve sheath diameter and common carotid artery blood flow. For each time point, three measurements were taken, and the average value was recorded. Other data were recorded by the anesthesiologist or anesthesia nurse.

In the Postanesthetic Care Unit (PACU), the following parameters were monitored and recorded: length of stay, mean arterial pressure, heart rate, postoperative nausea and vomiting, pain, rescue antiemetics, rescue analgesics, and rescue sulfentanil dose.

Being tested
operating position, pneumoperitoneum
Keywords
intracranial pressure, laparoscopic, optic nerve sheath diameter, ReverseTrendelenburg position, Trendelenburg position

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • operating positionDevice

    Also called the Trendelenburg position, the Reverse Trendelenburg position

    In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°.

  • pneumoperitoneumDevice

    Pneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg.

Study groups in NCT06669689
Study groupRoleWhat they receive
the TREND group (Trendelenburg position)In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°.
Receives: Device: operating position; Device: pneumoperitoneum
the Reverse Trendelenburg positionIn the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°
Receives: Device: operating position; Device: pneumoperitoneum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. common carotid artery (CCA) flow

    If it was significantly lower than pre-anesthetic, it was considered that the position and pneumoperitoneum affected the cerebral blood supply.

    Measured: From February 2023 to December 2023

Secondary outcomes (1)
  1. optic nerve sheath diameter (ONSD)

    If significantly higher than pre-anesthetic, it is thought that the position and pneumoperitoneum have increased intracranial pressure.

    Measured: From February 2023 to December 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start1 Feb 2023
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669689
Sponsor's protocol ID
2023-MER-26
Status last verified
Jan 2023
First submitted
28 Oct 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Recorded parameters were taken at five time points: before anesthesia (T1), after intubation (T2), after positional change (Trendelenburg or Reverse Trendelenburg) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5). Recorded parameters included mean arterial pressure (MAP), heart rate (HR), Bispectral index(BIS), Peak inspiratory pressure (PIP), end-tidal carbon dioxide concentration (ETCO2), Total volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD).

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopic Surgery, run by Xiaguang Duan at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

common carotid artery (CCA) flow (time frame: From February 2023 to December 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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