| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Anaesthesiology |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| 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
|
|
|
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.
|