| 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
|
|
|
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
|
|
|
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. |