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CompletedNCT06669689Updated Nov 1, 2024

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

An observational study in Laparoscopic Surgery, sponsored by Xiaguang Duan. Completed at 1 site in China. Open to female participants aged 29 Years to 62 Years. Per ClinicalTrials.gov, last updated 2024-11-01.

Sponsored by Xiaguang Duan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
29 Years to 62 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Laparoscopic Surgery

Keywords

  • intracranial pressure
  • laparoscopic
  • optic nerve sheath diameter
  • ReverseTrendelenburg position
  • Trendelenburg position
03

In context

Lead sponsor

Xiaguang Duan is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Years to 62 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • the TREND group (Trendelenburg position)

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

    Device: operating position · Device: pneumoperitoneum

  • the Reverse Trendelenburg position

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

    Device: operating position · Device: pneumoperitoneum

Interventions

  • Deviceoperating 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°.

    Also known as: the Trendelenburg position, the Reverse Trendelenburg position

  • Devicepneumoperitoneum

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: From February 2023 to December 2023

Secondary outcomes

  1. optic nerve sheath diameter (ONSD)

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

    Time frame: From February 2023 to December 2023

07

Study locations

1 site
  • Inner Mongolia Baogang Hospital
    Baotou, Inner Mongolia 014010, China
08

References and documents

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06669689
Lead sponsor
Xiaguang Duan
Responsible party
Xiaguang Duan (associate professor (university post), Inner Mongolia Baogang Hospital) — Sponsor-investigator
First posted
Nov 1, 2024
Start date
Feb 1, 2023
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Nov 1, 2024

Study contacts

Xiangyu Wang, undergraduate
principal investigator · Inner Mongolia Baogang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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