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CTRI Number  CTRI/2023/12/060490 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study of the correlation between hand grip strength and oxygen requirement after surgery under general anaesthesia 
Scientific Title of Study   Association of dynamometer based hand grip strength with postoperative oxygen requirement in patients undergoing general anaesthesia 
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 Akshay A Kamath 
Designation  Junior Resident 
Affiliation  Manipal Academy of Higher Education 
Address  Post-Graduate, Department of Anaesthesiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8105763251  
Fax    
Email  akshayakamath43@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shaila S Kamath 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Professor, Department of Anaesthesiology Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka. India - 576104

Dakshina Kannada
KARNATAKA
576104
India 
Phone  9844090231  
Fax    
Email  shaila.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Akshay A Kamath 
Designation  Junior Resident 
Affiliation  Manipal Academy of Higher Education 
Address  Post-Graduate, Department of Anaesthesiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8105763251  
Fax    
Email  akshayakamath43@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal  
 
Primary Sponsor  
Name  Dr Akshay A Kamath 
Address  Post-Graduate, Department of Anaesthesiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Other [(Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshay A Kamath  Durga Sanjeevani Manipal Hospital  Durga Sanjeevani Manipal Hospital,SH 67, Near Durga Parameshvari Temple, Kateel, Karnataka - 574148
Dakshina Kannada
KARNATAKA 		 8105763251

akshayakamath43@gmail.com 
Dr Akshay A Kamath  Government Wenlock District Hospital  Government Wenlock District Hospital, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA 		 8105763251

akshayakamath43@gmail.com 
Dr Akshay A Kamath  Kasturba Medical College, Attavar  Kasturba Medical College, Nandigudda Road, Attavar, Mangalore, Karnataka - 575002
Dakshina Kannada
KARNATAKA 		 8105763251

akshayakamath43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H95-H95||Intraoperative and postprocedural complications and disorders of ear and mastoid process, not elsewhere classified, (2) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) ASA (American society of Anaesthesiologists) 1 and 2 category patients
2) Adults aged 18-60 years of both genders
3) Elective surgeries of the non-dominant upper limb, head and neck under general anaesthesia
4) Surgical duration of greater than 3 hours
 
 
ExclusionCriteria 
Details  1) Patients refusal to participate in the study
2) ASA 3 and above category patients
3) Those with preexisting neuromuscular disease
4) Obese patients with a body mass index greater than or equal to 30 kg/m2
5) Patients with a history of chronic pulmonary diseases
6) Patients with cardiac, hepato-renal diseases
7) Pregnant patients  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
- Hand – grip strength in kilogram
- Peripheral saturation of oxygen (SpO2) 		 Pre-op (Baseline)
(Post-op) 30 min
60 min
90 min
120 min
150 min
180 min
210 min
240 min
300 min
360 min 
 
Secondary Outcome  
Outcome  TimePoints 
- Respiratory rate (RR)
- Duration of oxygen supplementation in hours 		 Pre-op (Baseline)
(Post-op) 30 min
60 min
90 min
120 min
150 min
180 min
210 min
240 min
300 min
360 min 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2024 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akshayakamath43@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study is an observational, single arm, multi-center study where we aim to objectively measure voluntary muscle control (hand grip strength) using a dynamometer to detect hypoventilation due to residual neuro-muscular blockade and its implication on post-operative oxygen requirement after general anaesthesia can be monitored. Primary outcome measures of hand grip strength (in kilogram) and peripheral saturation of oxygen (SpO2) will me measured half hourly till a duration of four hours and hourly till six hours. Secondary outcome measure of respiratory rate will also be simultaneously measured half hourly till a duration of four hours and hourly till six hours. Postoperative duration of oxygen requirement will also be noted. 
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