NCT04224532

Brief Summary

Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 8, 2020

Last Update Submit

June 3, 2020

Conditions

Intracranial Pressure IncreasePneumoperitoneum

Keywords

optic nerve sheath diameterintracranial pressurelaparoscopic cholecystectomypneumoperitoneum

Outcome Measures

Primary Outcomes (2)

  • Change in Optic Nerve Sheath Diameter

    The change in intracranial pressure via optic nerve sheath diameter measurement during laparoscopic cholecystectomy among 6 time point.

    Throughout the surgery

  • Change in regional cerebral oxygen saturation

    The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.

    Throughout the surgery

Secondary Outcomes (2)

  • Perioperative Hemodynamic Parameters

    Throughout the surgery

  • Perioperative Hemodynamic Parameters

    Throughout the surgery

Study Arms (2)

Group P

EXPERIMENTAL

Pneumoperitoneum is induced before reverse Trendelenburg position.

Procedure: Pneumoperitoneum Timing (Before Positioning)

Group RT

EXPERIMENTAL

Pneumoperitoneum is induced after reverse Trendelenburg position.

Procedure: Pneumoperitoneum Timing (After Positioning)

Interventions

Pneumoperitoneum Timing (Before Positioning)PROCEDURE

Before Reverse Trendelenburg Position

Group P
Pneumoperitoneum Timing (After Positioning)PROCEDURE

After Reverse Trendelenburg Position

Group RT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing laparoscopic cholecystectomy operation
  • Age between 18-65
  • ASA I-II
  • BMI ≤ 35

You may not qualify if:

  • Ophthalmologic disease and optic nerve pathology
  • Increased intracranial pressure
  • History of cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (4)

  • Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.

    PMID: 27956677BACKGROUND

  • Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.

    PMID: 25899811BACKGROUND

  • Sahay N, Sharma S, Bhadani UK, Singh A, Sinha C, Sahay A, Ranjan A, Agarwal M. Effect of Pneumoperitoneum and Patient Positioning on Intracranial Pressures during Laparoscopy: A Prospective Comparative Study. J Minim Invasive Gynecol. 2018 Jan;25(1):147-152. doi: 10.1016/j.jmig.2017.07.031. Epub 2017 Sep 12.

    PMID: 28918894BACKGROUND

  • Demirgan S, Ozcan FG, Gemici EK, Guneyli HC, Yavuz E, Gulcicek OB, Selcan A. Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial. J Clin Monit Comput. 2021 Feb;35(1):89-99. doi: 10.1007/s10877-020-00608-6. Epub 2020 Oct 21.

    PMID: 33089454DERIVED

MeSH Terms

Conditions

Intracranial HypertensionPneumoperitoneum

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Serdar Demirgan, MD

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

January 8, 2020

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-01

Locations

TU(1)