| CTRI Number |
CTRI/2025/09/094406 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of total intravenous anaesthesia versus Inhalational Anaesthesia in Patients posted for Unilateral Zygomaticomaxillary Complex Fractures. |
|
Scientific Title of Study
|
Effects of Total Intravenous Anesthesia vs Balanced Inhalational Anesthesia on Hemodynamics Recovery & Safety in ZMC Fractures A Randomized Control Trial |
| 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 Abhinav Lambe |
| Designation |
Associate Professor |
| Affiliation |
Dr BVP RMC Loni |
| Address |
Department of Anaesthesiology and CC
Room No 23
First Floor
PMT PIMS
Loni Bk
Taluka Rahata
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8605587660 |
| Fax |
|
| Email |
abhinav3003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Lambe |
| Designation |
Associate Professor |
| Affiliation |
Dr BVP RMC Loni |
| Address |
Department of Anaesthesiology and CC
Room No 23
First Floor
PMT PIMS
Loni Bk
Taluka Rahata
MAHARASHTRA
413736
India |
| Phone |
8605587660 |
| Fax |
|
| Email |
abhinav3003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinav Lambe |
| Designation |
Associate Professor |
| Affiliation |
Dr BVP RMC Loni |
| Address |
Department of Anaesthesiology and CC
Room No 23
First Floor
PMT PIMS
Loni Bk
Taluka Rahata
MAHARASHTRA
413736
India |
| Phone |
8605587660 |
| Fax |
|
| Email |
abhinav3003@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhinav Lambe |
| Address |
Department of Anaesthesiology and CC
DBVPRMC
PMT PIMS
Loni |
| 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 |
| Dr Abhinav Lambe |
DVVPRH LONI |
Room number 23, first floor, new hospital building,
Dr. Vitthalrao Vikhe Patil Rural Hospital
PMT PIMS
Loni Bk
Taluka Rahata
District Ahmednagar
Ahmadnagar
MAHARASHTRA |
08605587660
abhinav3003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PIMS DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M265||Dentofacial functional abnormalities, (2) ICD-10 Condition: M843||Stress fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balanced Inhalational Anaesthesia |
Oxygen 50%
Nitrous Oxide 50%
Isoflurane Titrated to effect. |
| Intervention |
Nil |
Nil |
| Intervention |
TOTAL INTRAVENOUS ANAESTHESIA |
Inj Ketamine 1mg per kilogram per hour intravenous Infusion
Inj Dexmedetomidine 1mcg per kilogram per hour intravenous Infusion
Inj Propofol 1mg per kilogram per hour intravenous Infusion.
This Infusion will be Given till Maximum of 180 Minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Zygomaticomaxillary Complex Fractures
Elective Surgeries
ASA Physical Status 1 to 3
Procedure lasting up to 3 hours
Patients Willing for Participating in the study. |
|
| ExclusionCriteria |
| Details |
Emergency surgeries.
ASA 4 or above.
Known hypersensitivity to anaesthetic agents.
Pregnancy or lactation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Total Intravenous Anaesthesia (TIVA) and balanced inhalational anaesthesia in terms of intraoperative haemodynamic stability, recovery profiles, and safety in patients undergoing ZMC fracture surgeries.
To evaluate intraoperative haemodynamic parameters (mean arterial pressure, heart rate, and oxygen saturation).
To assess postoperative recovery, including extubation time, pain scores, and incidence of PONV.
|
To compare Total Intravenous Anaesthesia (TIVA) and balanced inhalational anaesthesia in terms of intraoperative haemodynamic stability, recovery profiles, and safety in patients undergoing ZMC fracture surgeries.
To evaluate intraoperative haemodynamic parameters (mean arterial pressure, heart rate, and oxygen saturation).
To assess postoperative recovery, including extubation time, pain scores, and incidence of PONV.
To determine the incidence of intraoperative and postoperative adverse events in both groups.
To measure patient satisfaction with each anaesthetic technique.
Intraoperative Awareness.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the incidence of intraoperative & postoperative adverse events in both groups.
To measure patient satisfaction with each anaesthetic technique.
Intraoperative Awareness.
|
Incidence of intraoperative & postoperative adverse events will be assessed at 30, 60 & 120 minutes post extubation.
Patient satisfaction with each anesthetic technique assessed at 120th minute.
Intraoperative Awareness assessed at 30, 60 & 120 minutes post extubation. |
|
|
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)
|
25/09/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary Purpose of the Protocol
The primary purpose of this protocol is to compare two established anaesthetic techniques Total Intravenous Anaesthesia and Balanced Inhalational Anaesthesia in patients undergoing elective Zygomatico-Maxillary Complex (ZMC) fracture surgeries. The study aims to determine which technique offers better haemodynamic stability, faster recovery, and improved safety, thereby guiding anaesthesiologists in selecting the most appropriate approach for such surgeries. Study Hypothesi
It is hypothesised that TIVA will provide superior intraoperative haemodynamic stability, faster postoperative recovery, and lower incidence of complications such as postoperative nausea and vomiting compared to Balanced Inhalational Anaesthesia in ZMC fracture surgeries. |