Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CS

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

Group Type EXPERIMENTAL

Standard abdominal pressure

Intervention Type DEVICE

Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Conventional neuromuscular blockade

Intervention Type DRUG

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

DS

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

Group Type EXPERIMENTAL

Standard abdominal pressure

Intervention Type DEVICE

Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Deep neuromuscular blockade

Intervention Type DRUG

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

DL

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

Group Type EXPERIMENTAL

Low abdominal pressure

Intervention Type DEVICE

Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery

Deep neuromuscular blockade

Intervention Type DRUG

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

Interventions

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Standard abdominal pressure

Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Intervention Type DEVICE

Low abdominal pressure

Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery

Intervention Type DEVICE

Conventional neuromuscular blockade

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

Intervention Type DRUG

Deep neuromuscular blockade

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

Intervention Type DRUG

Other Intervention Names

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Abdominal pressure

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No