NCT02249585

Brief Summary

The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration 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

Study Start

First participant enrolled

September 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

September 19, 2014

Results QC Date

May 31, 2017

Last Update Submit

November 9, 2017

Conditions

Cardiac Index

Outcome Measures

Primary Outcomes (1)

  • Cardiac Index

    Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.

    30 min after onset of laparoscopy

Secondary Outcomes (5)

  • Mean Arterial Blood Pressure (MBP)

    1, 30, 60, 90, and 120 minutes after onset of laparoscopy

  • Stroke Volume Index (SVI)

    1, 30, 60, 90, 120 min after onset of laparoscopy

  • PaO2

    1, 30, 60, 90, and 120 minutes after onset of laparoscopy

  • Pulmonary Compliance

    1, 30, 60, 90, and 120 minutes after onset of laparoscopy

  • Surgical Rating Scale

    1 min after laparoscopic procedure

Study Arms (3)

CS

EXPERIMENTAL

Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.

Device: Standard abdominal pressureDrug: Conventional neuromuscular blockade

DS

EXPERIMENTAL

Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.

Device: Standard abdominal pressureDrug: Deep neuromuscular blockade

DL

EXPERIMENTAL

Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.

Device: Low abdominal pressureDrug: Deep neuromuscular blockade

Interventions

Standard abdominal pressureDEVICE

Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

CSDS
Low abdominal pressureDEVICE

Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery

Also known as: Abdominal pressure
DL
Conventional neuromuscular blockadeDRUG

Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch

CS
Deep neuromuscular blockadeDRUG

Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch

DLDS

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for laparoscopic colon surgery under Trendelenberg position

You may not qualify if:

  • ASA classification IV
  • Unable to make a written, informed consent
  • Allergic to neuromuscular blocking agents, anesthetics, opioids
  • Patients with neuromuscular disease
  • Hepatic failure
  • Renal failure
  • History of malignant hyperthermia
  • Morbid obesity with BMI\>35 kg/m2
  • Patients enrolled in another clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Lower Body Negative Pressure

Intervention Hierarchy (Ancestors)

DecompressionTherapeutics

Results Point of Contact

Title
Dr Kook Hyun Lee, MD, PhD
Organization
Seoul National University Hospital
leekh@snu.ac.kr
82-2-2072-2467

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 25, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 6, 2018

Results First Posted

August 6, 2018

Record last verified: 2017-11

Locations

KR(1)