Atelectasis, Postoperative Clinical Trial
Official title:
Effects of Sugammadex and Conventional Reversal on Lung Function in Laparoscopic Abdominal Surgery
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | University of Science Malaysia Hospital | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Rhendra Hardy Mohamad Zaini |
Malaysia,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Atelectasis | 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 | |
Secondary | Length of stay | 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 |
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