Effects of Sugammadex and Conventional Reversal on Lung Function in Laparoscopic Abdominal Surgery

NCT06210165 | Unknown

• 1 other identifier: USM/JEPeM/22050289
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clincal trial is to determine the differences in few parameter of lung function (ie Forced Vital Capacity (FCV)) between Sugammadex and conventional reversal in laparoscopic abdominal surgery. The main questions it aims to answer are:

1. 1.Is there differences in the pulmonary function test preoperative and post extubation between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
2. 2.Is there differences in the size of atelectasis area between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
3. 3.Is there differences between sugammadex and conventional reversal in postoperative mean length of stay in laparoscopic abdominal surgery?
4. 4.to do baseline spirometry before operation
5. 5.to be examined for lung ultrasound before operation
6. 6.to be given either sugammadex or neostigmine as reversal after operation is completed
7. 7.to repeat spirometry after operation for few times
8. 8.to be examined for lung ultrasound after operation

Conditions

Atelectasis, Postoperative; Pulmonary Function; Newborn, Abnormal

Outcome Measures

Primary Outcomes (1)

• Lung Function

  compare the Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), and FEV1/FVC using portable spirometry preoperative and post extubation between sugammadex and conventional reversal in laparoscopic abdominal surgery

  Preoperative (Hour 1)to 24H post extubation (Hour 24)

Secondary Outcomes (2)

• Atelectasis

  Preoperative (baseline) and 20 minutes post extubation

• Length of stay

  Through study completion, an average one week

Study Arms (2)

Sugammadex

EXPERIMENTAL

IV Sugammadex 4mg/kg once after Train of Four ratio 0.7 to 0.9

Drug: Sugammadex

Neostigmine and atropine

ACTIVE COMPARATOR

IV Neostigmine 40mcg/kg and IV Atropine 10mcg/kg once after Train of Four ratio 0.7 to 0.9

Drug: Neostigmine and atropine

Interventions

Sugammadex DRUG

IV Sugammadex 4mg/kg stat once TOF ratio 0.7-0.9 after completing surgery

Also known as: Interventional Reversal

Sugammadex

Neostigmine and atropine DRUG

IV neostigmine 40mcg/kg in combination with IV atropine 10mcg/kg stat once TOF ratio 0.7-0.9 after completing surgery

Also known as: Conventional reversal

Neostigmine and atropine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed / suspected: appendicitis or cholelithiasis
• Planned for laparoscopic operation under general anaesthesia
• ASA I-III

You may not qualify if:

• Unstable haemodynamic status
• Patient refusal to participate
• Altered mental status, cognitive function or mental disorder
• Admission to postoperative care unit (PACU) under mechanical ventilation
• Hypersensitivity to any of the drugs
• Acute or chronic lung diseases
• Neuromuscular disorders
• Myocardial infarction or coronary occlusion three months prior surgery
• Obesity BMI more or equal 30
• Intubation prior operating room arrival
• Pregnancy
• Converted to open surgery

Sponsors & Collaborators

• Rhendra Hardy Mohamad Zaini: lead

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (27)

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• Yu J, Park JY, Lee Y, Hwang JH, Kim YK. Sugammadex versus neostigmine on postoperative pulmonary complications after robot-assisted laparoscopic prostatectomy: a propensity score-matched analysis. J Anesth. 2021 Apr;35(2):262-269. doi: 10.1007/s00540-021-02910-2. Epub 2021 Mar 8.

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MeSH Terms

Conditions

Pulmonary Atelectasis; Antisocial Personality Disorder

Interventions

Sugammadex; Neostigmine; Atropine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• NIK MUHAMMAD 'AIZAT 'ADROS, MBBS

  Hospital Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIK MUHAMMAD 'AIZAT 'ADROS, MBBS

CONTACT

+60145333560; aizatadros@gmail.com

RHENDRA HARDY MOHAMAD ZAINI, MD

CONTACT

+6097673000; rhendra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Dr

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: January 18, 2024
• Study Start: December 7, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

MY (1)