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CTRI Number  CTRI/2025/09/094500 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Early recovery from anaesthesia- A comparison between two common modes of anaesthesia: inhalational and total intravenous in short gynaecological surgeries 
Scientific Title of Study   A comparison between inhalational and total intravenous anaesthesia in providing an early recovery in short gynaecological surgeries: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitu PV 
Designation  Professor 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences

Ernakulam
KERALA
682041
India 
Phone  9495962020  
Fax    
Email  nituveesundeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aswinin D 
Designation  Resident 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences

Ernakulam
KERALA
682041
India 
Phone  9446322702  
Fax    
Email  aswinin99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitu PV 
Designation  Professor 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences

Ernakulam
KERALA
682041
India 
Phone  9495962020  
Fax    
Email  nituveesundeep@gmail.com  
 
Source of Monetary or Material Support  
Amrita Institute Of Medical Sciences 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences 
Address  Edappaly, Kochi, 682041 
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 Aswinin D  Amrita Institute of medical Sciences  Gyneacology OT,Dept of Anaesthesia
Ernakulam
KERALA 
9446322702

aswinin99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Total inhalational anaesthesia group  Patients will receive total inhalational anaesthesia with O2, N2O and sevoflurane  
Comparator Agent  Total intravenous anaesthesia group  Ptients will receive total intravenous anaesthesia with midazolam, ketamine, fentanyl and titrating doses of propofol  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing dilatation and curettage(D and C) procedures as ambulatory day case procedures under general anaesthesia will be included 
 
ExclusionCriteria 
Details  Patients with known allergy to the drugs used will be excluded from the study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time taken to respond to verbal commands at the end of surgery between 2 groups of patients  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the postoperative nausea and vomiting, surgeon and patient satisfaction   At 1 hr post op 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   01/10/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Introduction

The choice of anaesthetic agents and techniques could  influence the occurrence of complications such as postoperative nausea and vomiting (PONV), postoperative behavioural disturbances and cardiorespiratory complications and thus delay discharge. Dilatation and curettage(D&C) procedures that involve general anaesthesia are performed with combination of intravenous with  volatile anaesthetics or propofol-based total intravenous anaesthesia. Both these techniques are safe and provide appropriate conditions for surgery. Total inhalation anesthesia is a general anesthetic that uses only inhaled anaesthetics drugs to induce and maintain unconsciousness and is rarely used .Hence it is  unclear whether TIVA or TIA  anaesthesia regimen is better for  short day care procedures like D&C. The present study will be conducted to compare the use of the inhalation anaesthesia technique using sevoflurane and nitrous oxide with the TIVA technique, using propofol and fentanyl.The primary objective of the study will be to compare the incidence and severity of post operative nausea and vomiting between patients receiving inhalational and those receiving total intravenous anaesthesia.

 

Methods

After obtaining approval from the hospital Ethics Committee and securing the CTRI clearance, patients will be randomly allocated to either of the two groups [Group P or Group S ] using computer generated random sequence of numbering. Concealment of allocation will be ensured by sequentially numbered opaque sealed envelopes.

Female surgical patients scheduled for D&C procedure will be recruited after a thorough pre-anaesthetic evaluation and consent.

Patients will be fasted 6 hours for solids and 2 hours for clear fluids. No premedication will be given as per the hospital protocol. Pre operatively, on the day of surgery, patients will be explained about the procedure, satisfaction scores and consent will be taken.

In the operation theatre, an intravenous line will be secured and injection glycopyrrolate 0.2mg will be  given to all patients and all pre induction monitors-ECG, NIBP, saturation probe and EtCO2will be attached.

Patients in group P will be induced with iv midazolam 2mg,  fentanyl 1.5mcg/kg, ketamine 0.5mg/kg and titrated doses of propofol till the patient loses consciousness. Additional increments of 10mg propofol will be given when the patient shows signs of inadequate anaesthesia like spontaneous movement, resistance to leg elevation during positioning of the patient or an increase in heart rate or BP and increase in the depth of ventilation. The patients in group S will be induced with 50% nitrous oxide and 5% sevoflurane in oxygen till loss of consciousness and then sevoflurane will be reduced to 2%.

Patients in both groups will be maintained on spontaneous ventilation with a face mask and closed circuit.

All patients will be provided with iv 4mg Ondansetron and 1g paracetamol at the end of surgery. The time to respond to commands after surgery and the surgeon’s satisfaction with anaesthesia provided will be noted in both groups.

PONV, requirement of additional anti-emetic and analgesic, patient satisfaction, time to ambulate and discharge the patient and the cost of anaesthesia will also be noted.

 
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