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CTRI Number  CTRI/2025/04/083913 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 12/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In this study compares two different drugs Sugammadex and Neostigmine/glycopyrrolate combination to see their effect on ability of adults to breathe out air after laparoscopic cholecystectomy 
Scientific Title of Study
Modification(s)  
Effect of sugammadex versus neostogmine/glycopyrrolate combination on peak expiratory flow rates in adult patients undergoing laparoscopic surgery  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Penna Srihitha 
Designation  Junior Resident 
Affiliation  PGIMER CHANDIGARH 
Address  Anaesthesia office Department of Anaesthesiology and Intensive care level 4,Nehru Hospital,PGIMER Chandigarh CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  6304215594  
Fax    
Email  srihithapenna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikas Saini 
Designation  Professor 
Affiliation  PGIMER CHANDIGARH 
Address  Anaesthesia office Department of Anaesthesiology and Intensive care level 4,Nehru Hospital,PGIMER Chandigarh CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008119  
Fax    
Email  drvsaini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikas Saini 
Designation  Professor 
Affiliation  PGIMER CHANDIGARH 
Address  Anaesthesia office Department of Anaesthesiology and Intensive care level 4,Nehru Hospital,PGIMER Chandigarh CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008119  
Fax    
Email  drvsaini@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh Pincode-160012 
 
Primary Sponsor  
Name  Dr Penna Srihitha 
Address  Department of Anaesthesiology and Intensive care, level 4, Nehru Hospital, PGIMER CHANDIGARH 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srihitha Penna  PGIMER CHANDIGARH  Nehru Hospital Operation Theatre Complex, Level 4 Nehru Extension Block Operation Theatre, Level 4 PGIMER Chandigarh Chandigarh Pin code-160012
Chandigarh
CHANDIGARH 
6304215594

srihithapenna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine+glycopyrrolate  Dose of neostigmine-50mcg/kg Dose of glycopyrrolate- 10mcg/kg frequency- one time route-Intravenous duration-1 hour 
Intervention  sugammadex  TO SEE THE EFFECT OF SUGAMMADEX ON PEAK EXPIRATORY FLOW RATES IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1-3, scheduled for laparoscopic cholecystectomy  
 
ExclusionCriteria 
Details  previously diagnosed respiratory disorders, BMI more than 30 kg/m2, Uncooperative patient, patient for emergency surgery, patients allergic to sugammadex or neostigmine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare peak expiratory flow rates  30minutes post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time interval  Administration of reversal agent to extubation  
Time to attain TOF more than 0.9   
Need for re intubation   Post extubation  
Incidence of PPC  post operative 
To compare global lung ultrasound scores  30minutes post extubation  
Time taken for modified aldrete score to reach more than 8  Post operative  
To note total duration of pneumoperitoneum  Intraoperative 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Neuromuscular blocking drugs (NMB), both depolarizing and nondepolarizing are one of the

commonly used drugs in Anaesthesia. They make intubation easy and provide muscle relaxation

during crucial steps in an operation and improve surgical conditions. But their usage may lead to few

complications when the muscle relaxation effect is not adequately reversed after surgery. When NMB

drugs effect is inadequately reversed it may lead to various untoward events like reintubation, upper

airway obstruction, decreased functional residual capacity, pneumonia, atelectasis and increased

duration of stay in the hosipital.

Sugammadex is a modified gamma-cyclodextrin and it is a drug used for reversal of

vecuronium, rocuronium induced neuro muscular blockade. Unlike traditional reversal agents like

neostigmine, whose mechanism of action is inhibiting acetylcholinesterase to increase levels of

acetylcholine at the neuro muscular junction, Sugammadex forms one-to-one complexes with neuro

muscular blocking drugs (vecuronium, rocuronium) and decreases plasma concentration of these

drugs. This mechanism provides rapid and complete reversal of NMB and allows faster recovery of

muscle function and safe emergence from anaesthesia.

Peak expiratory flow rate (PEFR) is the instantaneous velocity of the expiratory flow during

the pulmonary function test, which reflects the respiratory muscle strength and any obstruction in the

airway. It reflects the reduction in pulmonary function which is caused by Residual Neuro muscular

blockade (RNMB).PEFR is a useful tool for assessing post operative pulmonary complications.

In this study All the patients will undergo pre anaesthesia check up (General, physical, Systemic examination) and routine investigations before surgery. The patient will be maintained NPO 8hours for solids and 

2hrs for clear fluids. Pre-operative peak expiratory flow rates and global lung ultrasound will be done. On the day of surgery patient is taken into the operation theatre and ASA standard monitoring will be done including Spo2,NIBP, ECG, Heart rate, Temperature, NMT. IV cannulation will be done(18G/20G). All the patients will be preoxygenated and Fentanyl (2mcg/kg), Propofol(1.52mg/kg), vecuronium(0.1mg/kg) will be administered. Patient will be intubated with single lumen endotracheal tube. Anaesthesia will be maintained with Isoflurane (50% oxygen and 50% air mixture). Vecuronium maintenance dose will be given (0.015mg/kg) to maintain TOF count < 2. 

Intra operatively total duration of pneumoperitoneum will be noted. For reversal of neuromuscular blockade patients in neostigmine group will receive Neostigmine (50mcg/kg) +glycopyrrolate (10mcg/kg) administered when TOF count will be >4 or Sugammadex (2mg/kg) will be given in group S. Time interval from administration of reversal agent to extubation will be noted. Time to achieve modified Aldrete score >8 will be  noted. Post operative peak expiratory flow rates and global lung ultrasound scores will be noted 30min post extubation.



 
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