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CTRI Number  CTRI/2023/08/056753 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 20/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Measuring onset of neuromuscular monitoring at adductor pollicis and trapezius muscle as indicator of favourable intubating conditions 
Scientific Title of Study   Comparative evaluation of neuromuscular monitoring at the adductor pollicis and trapezius muscle as indicator of favourable intubating conditions 
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.Amandeep Kaur 
Designation  Secondary DNB Resident, Anaesthesia 
Affiliation  Max Super Speciality Hospital, Mohali 
Address  Max Super Speciality Hospital, Mohali, Sector 56, Phase VI, SAS Nagar, PUNJAB

Chandigarh
CHANDIGARH
160055
India 
Phone  8146356800  
Fax    
Email  amandeepkaur16894@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr YK Batra 
Designation  Head of Department 
Affiliation  Max Super Speciality Hospital, Mohali 
Address  Department of Anesthesia and Pain Management Max Super Speciality Hospital, Mohali, Punjab

Chandigarh
CHANDIGARH
160055
India 
Phone  9646624870  
Fax    
Email  ykbatrapgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Amandeep Kaur 
Designation  Secondary DNB Resident, Anaesthesia 
Affiliation  Max Super Speciality Hospital, Mohali 
Address  Max Super Speciality Hospital, Mohali, Sector 56, Phase VI, SAS Nagar, PUNJAB

Chandigarh
CHANDIGARH
160055
India 
Phone  8146356800  
Fax    
Email  amandeepkaur16894@gmail.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hospital, near Civil Hospital, phase-6, Mohali, Punjab 
 
Primary Sponsor  
Name  MAX SUPER SPECIALITY HOSPITAL 
Address  MAX SUPER SPECIALITY HOSPITAL, MOHALI, SECTOR 56, PHASE VI, PUNJAB, CHANDIGARH 
Type of Sponsor  Private hospital/clinic 
 
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 
DrAmandeep Kaur  Max Super Specialty Hospital, Mohali  Department of Anaesthesia and Pain management, room no F07, 1st floor.
Chandigarh
CHANDIGARH 		 8146356800

amandeepkaur16894@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Max Super Specialty Hospital, Mohali  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 
Intervention  Neuromuscular monitoring at adductor pollicis muscle  Measurement of onset of neuromuscular monitoring at adductor pollicis muscle using TOF device and to look for favourbale intubating conditions.  
Intervention  Neuromuscular monitoring at trapezius muscle   Measurement of onset of neuromuscular monitoring at trapezius muscle using TOF device and to look for favourbale intubating conditions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. ASA grade I,II
2. Patients giving consent for the study
 
 
ExclusionCriteria 
Details  1. Patients refusing to give consent for the study
2. ASA Physical Status Classification ≥ III
3. Patients requiring an awake intubation
4. Allergies to drugs administered during the study
5. Neuromuscular disease
 
 
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 
onset time of neuromuscular block at the APM & trapezius muscle for endotracheal intubation  5 MINUTES 
 
Secondary Outcome  
Outcome  TimePoints 
To assess for acceptable intubation conditions using CL grade, vocal cord & diaphragmatic movements during laryngoscopy  5 MINUTES 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   31/08/2023 
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   This is a randomized, prospective clinical trial comparing onset of neuromuscular block at adductor pollicis and trapezius muscle after injection of rocuronium in 70 ASA I-II patients undergoing general anaesthesia. The purpose of the trial is to look for favourable intubating conditions after rocuronium injection.
Aim of this study is to evaluate trapezius muscle as indicator of favourable intubating conditions after neuromuscular blockage compared to adductor pollicis muscle.During intubation, inadequate muscle relaxation can lead to increased sympathetic stimulation and poor CL grade. Hence finding the adequate dosage of neuromuscular blocking agents by using peripheral nerve stimulators at different  muscle groups can lead to better intubating conditions.
 
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