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Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum

Primary Purpose

Gynecologic Disease, Neuromuscular Blockade

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gynecologic Disease focused on measuring deep neuromuscular block, low pressure pneumoperitoneum, laparoscopic gynaecological surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Science Malaysia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

deep neuromuscular block group

moderate neuromuscular block group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The adequacy of intraabdominal pressure in mmHg
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

Secondary Outcome Measures

The quality of surgical space
2. To compare quality of surgical space condition in patient receiving deep and moderate neuromuscular block in laparoscopic gynaecological surgery.
the distance between the skin to sacral promontary in centimetres (cm)
3. To compare skin to sacral promontory distance in patient in patient receiving moderate neuromuscular block and deep neuromuscular block in laparoscopic gynaecological surgery.
post operative pain
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)
shoulder tip pain using pain visual analogue score (VAS)
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)

Full Information

First Posted
December 30, 2020
Last Updated
January 16, 2023
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05689957
Brief Title
Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
Official Title
Evaluation of Surgical Condition During Laparoscopic Gynaecological Surgery in Patient With Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease, Neuromuscular Blockade
Keywords
deep neuromuscular block, low pressure pneumoperitoneum, laparoscopic gynaecological surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
deep neuromuscular block group
Arm Type
Experimental
Arm Description
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
Arm Title
moderate neuromuscular block group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
Intervention Description
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
Primary Outcome Measure Information:
Title
The adequacy of intraabdominal pressure in mmHg
Description
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
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
The quality of surgical space
Description
2. To compare quality of surgical space condition in patient receiving deep and moderate neuromuscular block in laparoscopic gynaecological surgery.
Time Frame
intraoperative
Title
the distance between the skin to sacral promontary in centimetres (cm)
Description
3. To compare skin to sacral promontory distance in patient in patient receiving moderate neuromuscular block and deep neuromuscular block in laparoscopic gynaecological surgery.
Time Frame
intaoperative
Title
post operative pain
Description
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)
Time Frame
24 hour post operation
Title
shoulder tip pain using pain visual analogue score (VAS)
Description
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)
Time Frame
24 hour post operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umairah Esa, MBBS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Science Malaysia Hospital
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

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Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum

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