Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum

January 16, 2023 updated by: Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia

Evaluation of Surgical Condition During Laparoscopic Gynaecological Surgery in Patient With Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum

The investigators hypothesized that deep neuromuscular block compare to moderate neuromuscular block would reduce the rate of increasing intraabdominal pressure and operation can be completely done in lower pressure pneumoperitoneum and would improve laparoscopic space by measuring distance from the sacral promontory to the inserted trocar in patients undergoing laparoscopic gynaecological surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic surgery has increasing popularity and slowly replacing conventional open surgery as it offers more benefit to patient and health care practitioner. The overall risk of complications during laparoscopic surgery is recognized to be lower than during laparotomy. Laparoscopic hysterectomy compare to open vaginal hysterectomy reduces postoperative pain, reduce post op analgesics requirement and shorter duration of hospital admission.1 However, the increase intra-abdominal pressure created during laparoscopic surgery can affect cardiovascular, pulmonary and renal physiology. Besides the risk of post-operative nausea and vomiting, it is also stated that the pneumoperitoneum created during laparoscopic surgery is an important factor in the cause of postoperative shoulder pain.2 Traditionally pneumoperitoneum created at 15mmHg3. Insufflation of intraabdominal carbon dioxide may cause post-operative shoulder pain up to 70% in some study in gynaecologic laparoscopic surgery. 4 Use a lower pressure pneumoperitoneum might decrease postoperative pain, decrease post-operative shoulder tip pain5 and reduce the risk of laparoscopic related complication6. Many studies used lower insufflation of intraabdominal pressure as an intraoperative intervention to reduce the complication7,8. However, a lower intraabdominal pressure may worsen surgical space and increase the risk of conversion to open surgery.

Though many factors contribute to the quality of surgical space include non-modifiable such as obesity, previous abdominal surgery and modifiable factors such as anaesthesia related factor, patient position and intraabdominal pressure. Numerous studies also have been carried out showing that deep neuromuscular block improves surgical condition in different type of laparoscopic surgery includes robotic assisted laparoscopic surgery.9,10,11 Currently with the advancement of technology where neuromuscular monitoring is widely available and the selective reversal binding agent suggamadex where post-operative complication of inadequate reversal can be markedly reduced, several studies have been done to observe the benefit of low intraabdominal pressure with deep neuromuscular block to surgical space quality and intraoperative complication related to high pressure intraabdominal complication compare to usual moderate block.9,10,12 However there is still few study objectively measure the possible effect of deep neuromuscular blocker on the surgical space and the ability of surgery to be completely done in low pressure pneumoperitoneum in laparoscopic gynaecological surgery.

This study will compare the rate of increasing intraabdominal pressure, skin to sacral promontary distance, and post operative pain between deep neuromuscular block and moderate neuromuscular block.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • University of Science Malaysia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age more than 18 years old
  • ASA I or II
  • schedule to undergo laparoscopic gynaecological surgery (laparoscopic hysterectomy and laparoscopic ovarian cystectomy in Hospital Universiti Sains Malaysia , Kubang Kerian, Kelantan

Exclusion Criteria:

  • Allergy to study drugs (rocuronium, suggamadex)
  • Serious cardiac and respiratory disease (reactive airway disease, upper respiratory tract infection)
  • Neurological or neuromuscular disease (epilepsy, family history and history of malignant hyperthermia etc.)
  • Pregnancy
  • Morbid obesity BMI>35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: deep neuromuscular block group
Group 1 (Induction with Rocuronium 0.6mg/kg + maintenance with intravenous Rocuronium rocuronium 8-12mcg/kg/minute (0.48-0.72 mg/kg/hour maintain PTC 0-1(deep block). (Study Group) intraoperatively
Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
both arm are using low pressure pneumoperitoneum in laparoscopic surgery, moderate and deep neuromuscular block are monitor with neuromuscular monitoring. if surgical condition is inadequate, surgeon are allowed to increase intraabdominal pressure as per standard care
Active Comparator: moderate neuromuscular block group
Group 2 (Induction with intravenous Rocuronium 0.6mg/kg + maintenance with intermittent intravenous Rocuronium 0.2mg/kg bolus. maintain PTC >1, TOF 0-2). Moderate block. (Control Group) intraoperatively
Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
both arm are using low pressure pneumoperitoneum in laparoscopic surgery, moderate and deep neuromuscular block are monitor with neuromuscular monitoring. if surgical condition is inadequate, surgeon are allowed to increase intraabdominal pressure as per standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adequacy of intraabdominal pressure in mmHg
Time Frame: intraoperative
1. To compare the rate of increasing intra-abdominal pressure (IAP) by the surgeon when they decide that the surgical conditions are inadequate for the operation in patient receiving deep neuromuscular block compare to moderate neuromuscular block in laparoscopic gynaecological surgery
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of surgical space
Time Frame: intraoperative
2. To compare quality of surgical space condition in patient receiving deep and moderate neuromuscular block in laparoscopic gynaecological surgery.
intraoperative
the distance between the skin to sacral promontary in centimetres (cm)
Time Frame: intaoperative
3. To compare skin to sacral promontory distance in patient in patient receiving moderate neuromuscular block and deep neuromuscular block in laparoscopic gynaecological surgery.
intaoperative
post operative pain
Time Frame: 24 hour post operation
To compare the post-operative pain and shoulder tip pain in patient receiving deep neuromuscular block and moderate neuromuscular block in laparoscopic gynaecological surgery by using visual analog pain score (VAS)
24 hour post operation
shoulder tip pain using pain visual analogue score (VAS)
Time Frame: 24 hour post operation
To compare shoulder tip pain in patient receiving deep neuromuscular block and moderate neuromuscular block in laparoscopic gynaecological surgery by using visual analog pain score (VAS)
24 hour post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Umairah Esa, MBBS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2020

Primary Completion (Actual)

December 13, 2021

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/20080410

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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