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CTRI Number  CTRI/2022/08/044874 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 17/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   frailty and muscular paralysis association after surgery under general anaesthesia 
Scientific Title of Study   Association between Pre-operative frailty and Post Operative residual paralysis in elderly patients undergoing surgery under general anaesthesia: A Prospective Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puneet Khanna 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, academic block

South
DELHI
110023
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Puneet Khanna 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, academic block


DELHI
110023
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Puneet Khanna 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, academic block


DELHI
110023
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Department of Anaesthesiology 
Type of Sponsor  Research institution and hospital 
 
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 
puneet khanna  AIIMS, NEW DELHI  deaprtemnt of anesthesiology, 5th floor, academic blcok, AIIMS, New Delhi
South
DELHI 
9873106516

k.punit@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute 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  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age above 60 years
2.Undergoing surgery of duration from 1-3 hours
3.Can give informed consent themselves 
 
ExclusionCriteria 
Details  1.Significant kidney disease (stage 4 kidney disease or higher).
2.Significant liver disease (Child-Pugh B or C class).
3.Allergic to neostigmine or sugammadex.
4.History of a neuromuscular disorder.
5.History of chronic obstructive pulmonary disease.
6.Pregnancy or nursing women.
7.Refusal to participate.
8.Arrhythmic disease or taking anti-arrhythmic drugs.
9.Inability to extubate at the end of surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
the ratio of the handgrip strength at TOF count of 0.9 to the TFIO at baseline  60 MINUTES 
 
Secondary Outcome  
Outcome  TimePoints 
(1) the ratio of the handgrip strength, parasternal intercostal muscle, diaphragm excursion at the time of TOF 0.9, cTOFr 0.9 and 30 min after PACU admission to baseline, respectively; (
2) the recovery time from TOFr 0.9 to TOFr 0.95 and to unity, respectively.
 
from pre induction to 30 minutes after surgery 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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)   31/08/2022 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Frailty is a common and morbid condition found with a higher prevalence in older adults before surgery (25%- 56%) than in community-dwelling elders (10%). Frailty has been conceptualized in two major ways: one includes decreased reserve to physiologic stress and is characterized by decline across organ systems; and the other is an accumulation of deficits, that is, the accumulation of comorbid states that can result in overall physiologic vulnerability. Frailty has been shown to correlate with poor postoperative outcomes (death, complications) in a wide rangeof major surgeries. A frailty screen that includes grip strength may not be best suited for a cervical spine population that often has cervical myelopathy. The preoperative testing facility may dictate the type of assessment possible; some preoperative clinic areas are not suitable for a 5-meter gait speed test.

Residual neuromuscular blockade is one of the most serious clinical problems in postoperative settings. It may also lead to significant increases in respiratory morbidity and health-care utilization while putting patients at additional risk. Even though the availability of new drugs and new protocols should help us prevent residual neuromuscular blockade, its incidence has not yet changed significantly.It is important that clinicians have information regarding variables that predict the duration of action of neuromuscular blocking drugs. The patient’s ability to raise and maintain the head for 5 seconds, show the tongue, open the eyes, or cough, and adequate tidal ventilation are frequently used to predict postoperative muscle relaxant recovery. However, these assessments are often not performed correctly. In addition, the above tests do not solely exclude clinically significant residual curarization after general anesthesia.

there are no studies on association between preoperative frailty and postoperativeresidual paralysis. Ultrasonography of diaphragm thickness may reveal residual effects of NMBAs in conscious patients

this study aims to determine the association between pre-operative frailty in elderly patients undergoing  surgery under general anaesthesia with post-operative residual neuromuscular paralysis. the secondary objective is to determine the association between residual neuromuscular paralysis and increased length of hospital stay, increased length of ICU stay, increased requirement of postoperative mechanical ventilation, increased mortality. 

 
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