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

NCT06669689 | Completed DMC FDA Device

• 1 other identifier: 2023-MER-26
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Surgery

Keywords

intracranial pressure; laparoscopic; optic nerve sheath diameter; ReverseTrendelenburg position; Trendelenburg position

Outcome Measures

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.

  From February 2023 to December 2023

Secondary Outcomes (1)

• optic nerve sheath diameter (ONSD)

  From February 2023 to December 2023

Study Arms (2)

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

operating position DEVICE

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

the Reverse Trendelenburg position; the TREND group (Trendelenburg position)

pneumoperitoneum DEVICE

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

the Reverse Trendelenburg position; the TREND group (Trendelenburg position)

Eligibility Criteria

• Age: 29 Years - 62 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Interventions

Pneumoperitoneum, Artificial

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xiangyu Wang, undergraduate

  Inner Mongolia Baogang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor (university post)

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: February 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 1, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: January 2025-January 2026

Locations

CN (1)