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Clinical Trials/NCT06210165
NCT06210165RecruitingNot Applicable

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

Rhendra Hardy Mohamad Zaini1 site in 1 country80 target enrollmentStarted: December 7, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Lung Function

Study Overview

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. 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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
  • Converted to open surgery

Arms & Interventions

Sugammadex

Experimental

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

Intervention: Sugammadex (Drug)

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

Intervention: Neostigmine and atropine (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Atelectasis(Preoperative (baseline) and 20 minutes post extubation)
  • Length of stay(Through study completion, an average one week)

Investigators

Sponsor
Rhendra Hardy Mohamad Zaini
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rhendra Hardy Mohamad Zaini

Associate Professor, Dr

Universiti Sains Malaysia

Study Sites (1)

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