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CTRI Number  CTRI/2025/03/082948 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparative study of mask ventilation vs mechanical mask ventilation with oxygen and isoflurane during induction and look for post operative nausea and vomiting . 
Scientific Title of Study   Effect of Manual mask ventilation Vs Mechanical mask ventilation with oxygen and isoflurane during induction for post operative nausea and vomiting in adult patients posted for general endotracheal 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  Dontukurthi V Sai Tarun 
Designation  Junior Resident 
Affiliation  JSS Hospital Mysuru 
Address  Department of anaesthesia,JSS hospital,Mysore,Karnataka Mysore Karnataka 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9666262881  
Fax    
Email  dvtarun10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Srinivas HT 
Designation  Professor  
Affiliation  JSS Hospital Mysuru 
Address  Department of anaesthesia,JSS hospital,Mysore,Karnataka Mysore

Mysore
KARNATAKA
570004
India 
Phone  9986079823  
Fax    
Email  drsrinivashtjss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Srinivas HT 
Designation  Professor  
Affiliation  JSS Hospital Mysuru 
Address  Department of anaesthesia,JSS hospital,Mysore,Karnataka Mysore

Mysore
KARNATAKA
570004
India 
Phone  9986079823  
Fax    
Email  drsrinivashtjss@gmail.com  
 
Source of Monetary or Material Support  
JSS medical college and Hospital Mysore karnataka 570004 India 
 
Primary Sponsor  
Name  JSSAHER 
Address  JSS medical college and Hospital mysore Karnataka 570004 India 
Type of Sponsor  Private medical college 
 
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 
Dr D V Sai Tarun  JSS Medical College and Hospital  Operation theatre complex third floor Jss hospital MG road,Agrahara Mysore,Karnataka 570004
Mysore
KARNATAKA 
9666262881

dvtarun10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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 
Intervention  Manual mask ventilation Vs Mechanical mask ventilation  Effect of Manual mask ventilation Vs Mechanical mask ventilation with oxygen and isoflurane for 4 mins during induction for post operative nausea and vomiting in adult patients posted for general endotracheal anaesthesia 
Intervention  Manual mask ventilation Vs Mechanical mask ventilation  Group Mechanicak mask ventilation: Case group will receive 100% oxygen with 1% Isoflurane and pressure control ventilation with 15 cmH2O and PEEP 5cms H2O after induction with propofol (1mg/kg) and vecuronium(0.1mg/kg)before intubation. Group manual mask ventilation : This will receive 100% oxygen with 1% Isoflurane and manual mask ventilation after induction with propofol (1mg/kg) and vecuronium(0.1mg/kg)before intubation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults of ASA physical status I/II
Age 18 to 60 years
Undergoing endotracheal intubations . 
 
ExclusionCriteria 
Details  Patients already on treatment with anti-emetics, steroid medication, or any other drug known to cause emesis currently or in the immediate past Patients with known hypersensitivity to isoflurane or propofol, Pregnant or nursing mothers, Hepatic, renal or cardiac insufficiency, Vomiting within 24 hours before surgery or of any organic etiology. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Occurance of Postoperative nausea and vomiting every 2nd hourly upto 6hours and every 6th hourly upto 24 hours  2nd hour ,4th hour,6th hour, 12th hour,18th hour and 24th hour 
 
Secondary Outcome  
Outcome  TimePoints 
1.Severity of Postoperative nausea & vomiting,
2. Number of rescue antiemetic medications required.
3. Assessment of Apfel scoring & comparison with the incidence & severity of Post operative nausea & vomting 
At the end of 24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/04/2025 
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  
70 adult patients of both gender who will be posted for surgeries required to undergo general endotracheal (ET) anaesthesia will be evaluated thoroughly as a part of preanaesthetic evaluation. The Apfel scoring for PONV will also be evaluated & the scores will be noted. All patients will be included in the study after obtaining informed consent. On the day of surgery, patients will be randomised into two groups using shuffled sealed opaque envelop technique.
GROUP PCV: Case group will receive 100% oxygen with 1% Isoflurane and pressure control ventilation with 15 cmH2O and PEEP 5cms H2O after induction with propofol and vecuronium before intubation.
GROUP MMV : Control group will receive 100% oxygen with 1% Isoflurane and manual mask ventilation after induction with propofol and vecuronium before intubation.
The anaesthetist who is involved in randomization of patients will also be involved in induction and intubation of both the groups of patients and further management and observation of the incidence of post operative nausea and vomiting will be by another anaesthesiologist. Thus the observer and the patient will be blinded for the study drug. Inj dexamethasone 4mg, Inj Midazolam 0.01mg/kg body weight and Inj. Fentanyl 1microgram/kg body weight will be given as a part of premedications. All the patients after preoxygenation with 100% oxygen for 3 minutes, will be induced with propofol 2mg/kg body weight till the loss of eye lash reflexes. 0.1 mg/kg body weight of vecuronium will be administered for all patients. All patients will be mask ventilated with 100% oxygen and 1% isoflurane and the mode of ventilation changes depending on the group they belong to for 5 minutes and intubated with appropriate ET tubes. Patients will be maintained on O2&N2O and Isoflurane. Intaroperative heart rate (HR) and blood pressure (BP) will be monitored and any haemodynamic instability will be managed as per the institutional protocol. Patients will be administered with Paracetamol 1gm IV and 75mg diclofenac IV 20 minutes before extubation. Inj. Ramosetron 0.3 mg IV will be administered in both the groups 20 minutes before the end of surgery. At the end of surgery, patients will be reversed with Neostigmine 0.05mg/kg and Glycopyrrolate 0.01mg/kg body weight. Time of recovery will be noted from the time of administering reversal drugs and patients satisfying the extubation criteria are extubated. All patients will be shifted to post anaesthesia care unit (PACU) and monitored. Incidence of post operative nausea and vomiting will be noted at 0 hour and every 2nd hourly upto 6 hours and every 6th hourly upto 24 hours in both groups. Incidence of post-operative vomiting will be noted and treated with Inj.Metoclopramide 10mg IV (as a rescue antiemetic) and the number of injections will be noted. Post operative nausea will be assessed with VAS (visual analogue scale). Post op analgesic requirement will be also noted. All patients will be interviewed regarding the occurrence of nausea and vomiting 2nd hourly upto 6 hours and every 6th hourly upto 24 hours in both groups and were asked to rank their nausea using a four-point verbal rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Patient satisfaction at 24 h post-surgery will be quantified using a three-point scale (0 = dissatisfied, 1 = neither satisfied nor dissatisfied, 2 = satisfied).
9.2 Study population and source of data: After receiving ethical clearance, a total of 35 subjects in each group will be enrolled into this study who are adults of ASA physical status I/II aged 18 to 60 years undergoing laparoscopic surgeries.
 
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