| CTRI Number |
CTRI/2025/09/094550 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare how long muscle strength takes to return after extubation when Atracurium is used in Laparoscopic and open abdominal surgery using Train of Four monitoring |
|
Scientific Title of Study
|
A prospective observational study to compare neuromuscular blockade recovery time with Train of Four after extubation when Atracurium is used as muscle relaxant In Laparoscopic versus open abdominal surgery |
| 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 Ibrahim Khan |
| Designation |
Junior resident |
| Affiliation |
Bharati vidyapeeth deemed to be university dhankawadi pune, |
| Address |
Department of Anaesthesia, Bharati vidyapeeth deemed to be university dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9686077268 |
| Fax |
|
| Email |
khanibrahim442@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sarojini bobde |
| Designation |
professor |
| Affiliation |
Bharati vidyapeeth deemed to be university dhankawadi pune, |
| Address |
Department of Anaesthesia, Bharati vidyapeeth deemed to be university dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822914122 |
| Fax |
|
| Email |
sarojini.bobde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ibrahim Khan |
| Designation |
Junior resident |
| Affiliation |
Bharati vidyapeeth deemed to be university dhankawadi pune, |
| Address |
Department of Anaesthesia, Bharati vidyapeeth deemed to be university dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9686077268 |
| Fax |
|
| Email |
khanibrahim442@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and research centre Medical College Satara Road, Dhankawadi,Pune-Maharashtra 411043, India |
|
|
Primary Sponsor
|
| Name |
Dr Ibrahim khan |
| Address |
Department of Anaesthesia,Bharati vidyapeeth deemed to be university,dhankawadi, pune, Maharastra 411043, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Md Ibrahim khan |
Bharati hospital and Research centre ,pune |
Department of Anaesthesia, 3rd floor-major operation theatre, Bharati Hospital and Research Centre, pune-satara road, pincode-411043 pune, MAHARASHTRA
Pune
MAHARASHTRA |
968607268
Khanibrahim442@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient undergoing laparoscopic and open abdominal surgeries
patient categories under American society of Anesthesiologist(ASA) Grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
patient with pre-existing Asthma, chronic bronchitis, Allergic rhinitis
patient having hypersensitivity to Atracurium
patient not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Neuromuscular Blockade Recovery Time Using Train of Four Monitoring After Extubation with Atracurium in Laparoscopic versus Open Abdominal surgery |
Train of Four monitoring post extubation every 5min till TOF ratio 0.9 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to study spontaneous recovery time from last dose of Atracurium to appearance of curare notch
To compare the ABG parameters in both groups at the beginning of reversal |
intra-operative hemodynamic assessment every 15min till the last dose Atracurium to time taken to achieve TOF 0.9 after extubation |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
10/09/2025 |
| 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="0"
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
|
After obtaining approval from
institutional ethical committee and written informed consent from all 54
patients as per sample size, fulfilling
the inclusion criteria, thorough pre-operative evaluation will be done. All the
patients will be divided into two groups- GROUP A (Laparoscopic abdominal
surgery) and GROUP B (Open abdominal surgery).
General Anaesthesia management
for both the groups will be done according to the standard protocol including-
Inj. Midazolam 0.05mg/kg, Inj. Fentanyl 2mcg/kg for premedication and sedation,
Inj. Propofol 2mg/kg for induction. Intubation will be done under the effect of
bolus dose of Inj. Atracurium 0.5mg/kg and maintenance will be done with O2,
Air and Sevoflurane 1-3% with MAC of 0.8-0.9 using closed circuit. Intermittent
dose of Inj. Atracurium 5mg as per the requirement will be given and total
quantity will be noted.
Intra-operative vital parameters
monitoring will be done including Pulse rate (PR), Blood pressure (BP), Oxygen
saturation (SpO2), End-tidal carbon dioxide (ETCO2). Time of Reversal of NM
Blockade will be decided by the anaesthesiologist after appearance of 1st
Curare notch and extubation will be done. The time interval from last dose of
Inj. Atracurium to the appearance of 1st Curare notch will be noted
and ABG sample will be sent.
Then the time of completion of
reversal and extubation will be noted accordingly. Quantitative assessment of
recovery of NM Blockade will be confirmed with TOF Reading immediately after
extubation. Patient will be monitored further in post operative care unit. To
avoid confounding factors like effect of inhalational agent on muscle
relaxation, concentration of sevoflurane will be monitored till the end of
surgical procedure and MAC will be Recorded.
|