| CTRI Number |
CTRI/2024/10/075761 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
How intraoperative events can lead to breathing problems in recovery post operative |
|
Scientific Title of Study
|
Association between residual neuromuscular blockade and critical respiratory events in post anesthesia care unit -An prospective observation 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 |
Dr Vungarala Aasritha |
| Designation |
post graduation |
| Affiliation |
K.S.Hegde Medical Academy Deralakatte Mangaluru 575018 |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
1206 L BEARYS APARTMENT, ULLAL
DAKSHINAKANNADA
KARNATAKA
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
1206 L BEARYS APARTMENT, ULLAL
DAKSHINAKANNADA
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9346253698 |
| Fax |
|
| Email |
aasrithav2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joylin D Souza |
| Designation |
Assistant professor |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9346253698 |
| Fax |
|
| Email |
drjoysteff@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joylin D Souza |
| Designation |
Assistant professor |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
1206 L BEARYS APARTMENT, ULLAL
DAKSHINAKANNADA
KARNATAKA
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
1206 L BEARYS APARTMENT, ULLAL
DAKSHINAKANNADA
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9346253698 |
| Fax |
|
| Email |
drjoysteff@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesilogy and critical care |
| Address |
K.S.Hegde Medical Academy
Deralakatte Mangaluru
K.S.Hegde Medical Academy
Deralakatte Mangaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
NA |
| 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 Vungarala Aasritha |
K.S.Hegde Medical Academy Deralakatte Mangaluru 575018 |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, KS HEGDE MEDICAL ACADEMY, P.O: NITHYANANDANAGAR, DERLAKATTE,
MANGALURU, KARNATAKA
Dakshina Kannada
KARNATAKA |
9346253698
aasrithav2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITTE Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for elective surgeries scheduled to undergo orotracheal intubation using non depolarizing muscle relaxants
ASA 1 to 3 |
|
| ExclusionCriteria |
| Details |
patients with neuromuscular diseases
patients with renal failure with GFR more than 60 and hepatomegaly
patients who are planned for postoperative intensive care
pregnancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO estimate the occurrence of residual neuromuscular blockade and to evaluate critical respiratory events with train of four |
TO estimate the occurrence of residual neuromuscular blockade and to evaluate critical respiratory events with train of four at 0 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to estimate the occurence of residual neuromuscular blockade and its association with critical respiratory events |
train of four measures at 10th 20th 30th minutes after shifting to post anesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/11/2024 |
| 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="6"
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
|
Neuromuscular blocking agents (NMBA) are used to facilitate airway management and ensure immobility during surgery thus improving operating conditions. Complications associated with their use most commonly arise when their paralytic effects have not disappeared or have not been adequately antagonized at the end of surgery This is called Residual neuromuscular blockade (RNMB) and is associated with adverse outcomes such as upper airway obstruction, reintubation, atelectasis, pneumonia, prolong stay in post anesthesia care unit (PACU) and decreased patient satisfaction Quantitatively RNMB is defined as a train of four ratio (TOFR) <0.9 in post anesthesia care unit (PACU) secondary to nondepolarizing muscle relaxant (NDMR) administration The frequency of RNMB ranges between 4 and 50 % depending on diagnostic criteria and type of NMBA drug used, administration of reversal agents and to a lesser extent the use of neuromuscular monitoring (NMM) Incidence of RNMB has seen a steady decline with the use of perioperative neuromuscular monitoring(NMM)It was estimated to be around 42% in 1979 in a cohort of 72 patients in a seminal report. This was due to the fact that RNMB was defined as TOFR <0.7 . Subsequently now a broad consensus has been arrived at, and TOFR more than or equal to 0.9 is confirmed to be adequate recovery of neuromuscular function. Despite this RNMB remains a frequent occurrence with incidence as high as 64 % It has been difficult to prove that RNMB is associated with significant mortality and morbidity due to the relatively low incidence of major adverse outcomes . This is because most patients tolerate RNMB of moderate depth but it is deleterious in patients with limited physiological reserve. The purpose of the study is to evaluate the occurrence of RNMB and to ascertain its association with critical respiratory events if any. After approval from institutional ethics committee, patients satisfying the inclusion criteria will be enrolled in the study, thorough preanesthetic evaluation will be conducted according to institutional protocol. General anesthesia will be given according to institutional protocol. In the PACU, baseline Ramsay’s sedation score will be noted. The patient’s arrival time at the PACU will be designated as point zero (T0). Acceleromyograph (TOF-Watch® stim pod) of the patient’s adductor pollicis muscle will be monitored in the form of TOFR. The stimulation current will be set at 25 to 30 mA to avoid patient discomfort. The average of two consecutive measurements will be made at a frequency of 2 Hz, with four pulses of 0.2 M s duration separated by 15 s TOFR values will be recorded at 0, 10, 20, and 30 min (T0, T1, T2, and T3, respectively).The patient’s arterial oxygen saturation (SpO2), Heart rate (HR), systolic and diastolic blood pressure (SBP &DBP) will be noted at 0,10,20,30 min In the presence of RNMB, additional reversal agents and their doses, as considered necessary will be administered. If any critical respiratory events are identified in PACU during the study, they will be appropriately managed as per institution protocol
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