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CTRI Number  CTRI/2025/08/093072 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see which muscle recovery medicine helps the gut recover sooner after laparoscopic surgery. 
Scientific Title of Study   Comparison of Neuromuscular reversal with Neostigmine and Glycopyrrolate verses Sugammadex on bowel motility recovery after Laparoscopic colorectal surgery.A prospective Randomised study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Kumari 
Designation  Post graduate Junior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences,Patna. 
Address  Ward Block 13 first floor DEPARTMENT OF ANESTHESIOLOGY IGIMS PATNA

Patna
BIHAR
800014
India 
Phone  8271776171  
Fax    
Email  drpriyankaintern12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vinod Kumar Verma 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences,Patna. 
Address  Ward block 13 first floor DEPARTMENT OF ANESTHESIOLOGY Indira Gandhi Institute of Medical Sciences Patna

Patna
BIHAR
800014
India 
Phone  8292000111  
Fax    
Email  drvvinodv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Vinod Kumar Verma 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences,Patna. 
Address  Ward block 13 first floor DEPARTMENT OF ANESTHESIOLOGY Indira Gandhi Institute of Medical Sciences Patna

Patna
BIHAR
800014
India 
Phone  8292000111  
Fax    
Email  drvvinodv@gmail.com  
 
Source of Monetary or Material Support  
IGIMS PATNA 
 
Primary Sponsor  
Name  Priyanka Kumari 
Address  Gen x landmark block D flat no201 Rps nagar Kaliket nagar Mainpura at T point Rps more Bailey road Patna 801503 
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 PRIYANKA KUMARI  IGIMS PATNA  Gastrointestinal surgery OT Number 10 and 11 Ward block 13 first floor
Patna
BIHAR 		 8271776171

drpriyankaintern12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: C180||Malignant neoplasm of cecum, (2) ICD-10 Condition: C182||Malignant neoplasm of ascending colon, (3) ICD-10 Condition: C181||Malignant neoplasm of appendix, (4) ICD-10 Condition: C187||Malignant neoplasm of sigmoid colon, (5) ICD-10 Condition: C184||Malignant neoplasm of transverse colon, (6) ICD-10 Condition: C183||Malignant neoplasm of hepatic flexure, (7) ICD-10 Condition: C185||Malignant neoplasm of splenic flexure, (8) ICD-10 Condition: C186||Malignant neoplasm of descending colon, (9) ICD-10 Condition: C188||Malignant neoplasm of overlappingsites of colon, (10) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (11) ICD-10 Condition: K510||Ulcerative (chronic) pancolitis, (12) ICD-10 Condition: K512||Ulcerative (chronic) proctitis, (13) ICD-10 Condition: K513||Ulcerative (chronic) rectosigmoiditis, (14) ICD-10 Condition: K514||Inflammatory polyps of colon, (15) ICD-10 Condition: K515||Left sided colitis, (16) ICD-10 Condition: K518||Other ulcerative colitis, (17) ICD-10 Condition: K519||Ulcerative colitis, unspecified, (18) ICD-10 Condition: D120||Benign neoplasm of cecum, (19) ICD-10 Condition: D122||Benign neoplasm of ascending colon, (20) ICD-10 Condition: D123||Benign neoplasm of transverse colon, (21) ICD-10 Condition: D121||Benign neoplasm of appendix, (22) ICD-10 Condition: D124||Benign neoplasm of descending colon, (23) ICD-10 Condition: D125||Benign neoplasm of sigmoid colon, (24) ICD-10 Condition: D126||Benign neoplasm of colon, unspecified, (25) ICD-10 Condition: D127||Benign neoplasm of rectosigmoid junction, (26) ICD-10 Condition: D128||Benign neoplasm of rectum, (27) ICD-10 Condition: D129||Benign neoplasm of anus and anal canal, (28) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (29) ICD-10 Condition: C20||Malignant neoplasm of rectum, (30) ICD-10 Condition: K573||Diverticular disease of large intestine without perforation or abscess, (31) ICD-10 Condition: K509||Crohns disease, unspecified, (32) ICD-10 Condition: K635||Polyp of colon, (33) ICD-10 Condition: K621||Rectal polyp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine with Glcopyrrolate  Dose- Neostigmine 0.05mg/kg and Glycopyrrolate 0.01mg/kg given intravenously after completion of surgery and return of spontaneous breathing. Return of bowel activity analysed within 24 hour postopertatively. 
Intervention  Sugammadex  Dose-2-4mg/kg body weight based on TOF COUNT. Given intravenously once after completion of surgery and return of spontaneous breathing. Return of Bowel activity analysed postoperatively within 24 hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Patients with ASA physical status I, II, or III.
2 Patients aged 18 years and above of either sex undergoing laparoscopic colorectal surgery.
3 Patients able to comprehend and willing to participate.
4 Patients scheduled for neuromuscular blockade reversal with either Neostigmine-glycopyrrolate or Sugammadex.
 
 
ExclusionCriteria 
Details  1 Patients who refuse to participate.
2 Patients with known hypersensitivity to neostigmine, glycopyrrolate, or sugammadex.
3 Patients with severe renal or hepatic dysfunction.
4 Patients with pre-existing bowel motility disorders.
5 Patients with significant cognitive impairment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Return of Bowel motility 24 hour postoperatively.  Return of Bowel motility 24 hour postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first oral intake.
Evaluate postoperative nausea and vomiting.
Assess total opioid consumption within 24hrs postoperatively. 		 first 24 hour postoperatively. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   01/09/2025 
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 Applicable 
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   This prospective randomised  study aims to evaluate the effect of neuromuscular blockade reversal using Neostigmine with Glycopyrrolate verses Sugammadex on postoperative bowel motility recovery in patients undergoing laparoscopic colorectal surgery. Delayed return of bowel motility is common postoperative complication and cause prolong hospital stay. While Neostigmine -Glycopyrrolate combination slows bowel recovery due to anticholinergic side effects, Sugammadex offers a novel mechanism of action lead to faster bowel motility recovery. The primary outcome is first postoperative bowel movement assessed by first flatus or stool passage. This study is based on the fact that Sugammadex leads to earlier bowel motility recovery compared to Neostigmine-Glycopyrrolate combination due to its unique mechanism of action and lack of anticholinergic side effects that  facilitates enhanced recovery, reducing postoperative complications and reduce hospital stay. 
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