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

January 6, 2024 updated by: Rhendra Hardy Mohamad Zaini

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. Is there differences in the pulmonary function test preoperative and post extubation between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
  2. Is there differences in the size of atelectasis area between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
  3. Is there differences between sugammadex and conventional reversal in postoperative mean length of stay in laparoscopic abdominal surgery?

Participants will be asked

  1. to do baseline spirometry before operation
  2. to be examined for lung ultrasound before operation
  3. to be given either sugammadex or neostigmine as reversal after operation is completed
  4. to repeat spirometry after operation for few times
  5. to be examined for lung ultrasound after operation

Researcher will compare sugammadex group and conventional group to see if any difference in term of lung function, size of atelectasis and length of stay.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative Pulmonary Complications (PPCs) are not uncommon. They increase healthcare resource usage as well as increase mortality of the patients. There are many definitions published in literature which can be considered as a composite outcome measure. This includes atelectasis, respiratory infection, respiratory failure, pleural effusion, pneumothorax, bronchospasm as well as aspiration pneumonitis (Jammer et al., 2015). After induction of general anaesthesia, the respiratory system changes occur immediately: muscle function and respiratory drive change, volume of lungs decreases, and atelectasis occurs in more than 75% of patients who were given neuromuscular blocking agent,

The problem and rationale of the study are described in the following paragraphs according to three postoperative conditions, 1) pulmonary function, 2) atelectasis, and 3) postoperative length of stay:

Postoperative pulmonary complications are one of the major problems after a surgery. Even if the surgery was successful, patient will still be facing morbidity or even mortality after the surgery. The risk of PPCs increases in patients having respiratory problem such as asthma, chronic obstructive pulmonary disease (COPD) and smoker . Many studies have shown the comparison between Sugammadex and conventionally used Neostigmine with respect to PPCs. However, studies regarding Sugammadex and Neostigmine in term of pulmonary function postoperative are still scarce as only two studies were found to comment directly on pulmonary function by using spirometry between neostigmine and sugammadex. In those studies, it shown that no significant different in term of spirometry volume postoperative between sugammadex and neostigmine . The authors believed postoperative analgesia plays important role in reported preservation of FVC.

Atelectasis as one of the commonest PPC can be worsen especially in laparoscopic surgery by the effect of Trendelenburg position and pneumoperitoneum. Residual paralysis even not in such condition (Trendelenburg, pneumoperitoneum) has been demonstrated to contribute to impaired upper airway and pulmonary function as well as respiratory adverse events in PACU and might make the atelectasis even worse. This shows that there is a need for an effective and complete reversal of neuromuscular blocker to prevent such event.

The length of stay after operation is important as it may present the quality of the health care system. However, there are many factors that can contribute to length of stay postoperative where postoperative pulmonary complications is one of the greatest contributors. A study which conducted by Ledowski et al. on elderly group more than 75 years old in centres across 5 countries (South Korea, Malaysia, Australia, Hungary, Netherlands) regarding comparison neostigmine and sugammadex showed that there is no significant different in length of stay. Only in Malaysia Ledowski et.al found that there is significant difference in terms of length of stay. Thus, further study is needed to compare the post operative length of stay between patients reversed with Sugammadex and Neostigmine.

From reviews of literatures, there is a gap in studies involving comparison of the effect of sugammadex and neostigmine as reversal. The gap lies in 1) the scarcity of studies involving Sugammadex and Neostigmine in terms of pulmonary function postoperative, 2) a need for an effective and complete reversal of neuromuscular blocker, and 3) further study on postoperative length of stay is needed.

Research Question(s)

  1. Are there differences in the pulmonary function test preoperative and post extubation between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
  2. Are there differences in the size of atelectasis area between Sugammadex and conventional reversal in laparoscopic abdominal surgery?
  3. Are there differences between sugammadex and conventional reversal in postoperative mean length of stay in laparoscopic abdominal surgery?

Thus, we formulate from the research questions with null hypothesis as below:

  1. There is no difference in Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), and FEV1/FVC preoperative and post extubation between Sugammadex and conventional reversal group in laparoscopic abdominal surgery
  2. There is no difference in the size of atelectasis area using ultrasonography preoperative and post extubation between sugammadex and conventional reversal in laparoscopic abdominal surgery
  3. There is no difference in mean postoperative length of stay (days) in hospital between sugammadex and conventional reversal in laparoscopic abdominal surgery Objective General: To compare the effect on lung function between sugammadex and conventional reversal in laparoscopic abdominal surgery

Specific:

  1. To 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
  2. To identify and compare the size of atelectasis area using ultrasonography preoperative and post extubation between sugammadex and conventional reversal in laparoscopic abdominal surgery
  3. To compare mean postoperative length of stay (days) in hospital between sugammadex and conventional reversal in laparoscopic abdominal surgery

All data collection will be collected at Hospital Universiti Sains Malaysia, Kubang Kerian. Patient will be identified based on inclusion and exclusion criteria from locations listed below:

  1. Anaesthesia clinic
  2. In the ward, during review by preanaesthesia review for the elective operation in the following day
  3. In the ward, when cases are notified for operations as emergency case
  4. In operation theatre, when cases notified arrived for emergency operation.

The informed consent will be obtained from patients either in ward, clinics or in Operation Theatre during emergency premedication at the airlock. The patient will be given ample time to decide on the participation. The consent for general anaesthesia also will be taken as part of standard practice. Related information such as fasting hours will be conveyed.

After consent is explained and taken, baseline spirometry and lung ultrasound (LUS) will be performed before general anaesthesia given, either in wards, clinics or operation theatre. This to get the baseline of pulmonary function as well as lung images. Spirometry will be performed following international recommendations but with patients in a semi recumbent position (40 degree) as recommended for postoperative position (Graham et al., 2019). FVC, FEV1 and forced expiratory flow 25-75% will be measured and recorded. Changes in lung aeration will be studied by LUS with the patient in the same position. LUS will be conducted on each lung in sagittal section at three predefined areas: parasternal, medial axillary line, and posterior axillary line (Lichtenstein, 2014). Brightness will be adjusted in setting to the brightest level in the bony surface of ribs. After that, the scale in cm2 will be set according to image resolutions in pixels. Presence of hepatization pattern of lung tissue will indicate the collapsed area. This suggesting atelectasis is present. The area will be measured in each area by taking the longest length vertically and horizontally, during end-expiration after freezing the image. The sum of all six area will be added, recorded and considered as size of atelectasis.

Patient will be induced by anaesthesiologist in-charge as routine clinical practice. Neuromuscular block will be performed using rocuronium prior intubation and monitored by train-of-four (TOF) Watch. Anaesthesiologist will be allowed to maintain TOF level according to usual criteria. Desflurane or sevoflurane will be used as maintenance.

After operation is completed, patient will be randomly assigned to receive either sugammadex 4mg/kg or neostigmine 40mcg/kg in combination with atropine 10mcg/kg using sealed opaque envelopes. The reversal will be given once the TOF ratio ranging between 0.7 to 0.9 as the diaphragm muscles and tidal volume are already back to normal (Wardhana et al., 2019). An extra dose of reversal is permitted by protocol, when needed, at the discretion of the attending anaesthesiologist. Patient will be extubated as usual local practice and will be sent to postoperative recovery room.

In order to ensure patient able to obey command, new spirometry will be performed in the postoperative recovery room only after 20 minutes of extubation with the same procedure and position used in the preoperative determinations. Postoperative clinical management will be conducted according to clinical preferences and local protocol. Additional lung ultrasound scan is performed as well at 20 minutes post extubation, just after spirometry. The spirometry is repeated at 60 minutes post extubation. All measurements will be recorded.

Another spirometry will be done 24H after operation in ward in the same manner and measurement will be recorded. The patient will be followed up in ward until discharge and the length of stay postoperative will be recorded.

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

  • Name: Rhendra Hardy Mohamad Zaini, MD
  • Phone Number: 6095 +6097673000
  • Email: rhendra@gmail.com

Study Contact Backup

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • University of Science Malaysia Hospital
        • Contact:
          • Rhendra Hardy Mohamad Zaini, MD
          • Phone Number: 6095 +6097673000
          • Email: rhendra@gmail.com
        • Principal Investigator:
          • Nik Muhammad 'Aizat 'Adros, MBBS
        • Sub-Investigator:
          • Umairah Esa, MBBS
        • Sub-Investigator:
          • Kamaruddin Ibrahim, MD
        • Sub-Investigator:
          • Rhendra Hardy Mohamad Zaini, MD

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unstable haemodynamic status
  2. Patient refusal to participate
  3. Altered mental status, cognitive function or mental disorder
  4. Admission to postoperative care unit (PACU) under mechanical ventilation
  5. Hypersensitivity to any of the drugs
  6. Acute or chronic lung diseases
  7. Neuromuscular disorders
  8. Myocardial infarction or coronary occlusion three months prior surgery
  9. Obesity BMI more or equal 30
  10. Intubation prior operating room arrival
  11. Pregnancy
  12. Converted to open surgery

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: Sugammadex
IV Sugammadex 4mg/kg once after Train of Four ratio 0.7 to 0.9
Drug: Sugammadex
IV Sugammadex 4mg/kg stat once TOF ratio 0.7-0.9 after completing surgery
Other Names:
  • Interventional Reversal
Active Comparator: Neostigmine and atropine
IV Neostigmine 40mcg/kg and IV Atropine 10mcg/kg once after Train of Four ratio 0.7 to 0.9
Drug: Neostigmine and atropine
IV neostigmine 40mcg/kg in combination with IV atropine 10mcg/kg stat once TOF ratio 0.7-0.9 after completing surgery
Other Names:
  • Conventional reversal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Function
Time Frame: Preoperative (Hour 1)to 24H post extubation (Hour 24)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atelectasis
Time Frame: Preoperative (baseline) and 20 minutes post extubation
compare the size of atelectasis area using ultrasonography preoperative and post extubation between sugammadex and conventional reversal in laparoscopic abdominal surgery.
Preoperative (baseline) and 20 minutes post extubation
Length of stay
Time Frame: Through study completion, an average one week
compare mean postoperative length of stay (days) in hospital between sugammadex and conventional reversal in laparoscopic abdominal surgery
Through study completion, an average one week

Collaborators and Investigators

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

Sponsor

Rhendra Hardy Mohamad Zaini

Investigators

  • Principal Investigator: NIK MUHAMMAD 'AIZAT 'ADROS, MBBS, Hospital Universiti Sains Malaysia

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 7, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/22050289

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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