| 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
|
|
|
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
|
|
|
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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