| CTRI Number |
CTRI/2026/03/105152 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Spinal Anaesthesia vs Total Intravenous Anaesthesia for brachytherapy in patients for carcinoma cervix |
|
Scientific Title of Study
|
Comparative Evaluation of Subarachnoid Block and Total Intravenous Anesthesia for Intracavitary Brachytherapy in Patients with Carcinoma of the Cervix.” |
| 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 HITARTHIBEN NARESHBHAI PATEL |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9825890389 |
| Fax |
|
| Email |
Hitarthipatel612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHAIRUNNISA KHAN |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319529231 |
| Fax |
|
| Email |
khankk786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KHAIRUNNISA KHAN |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319529231 |
| Fax |
|
| Email |
khankk786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawani Meghe, Wardha, 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College And Datta Meghe Institute Of Higher Education And Research |
| Address |
Sawangi Meghe,Wardha,Maharastra,India 442001 |
| 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 Hitarthiben Patel |
Jawaharlal Nehru Medical College |
Department of
Anaesthesiology
Jawaharlal Nehru
Medical College,
Sawangi Meghe,
Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9825890389
hitarthipatel612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe institute of Higher Education and Researvh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
subarachnoid block |
Procedure is usually carried out with the patient sitting or lateral decubitus.The access site is identified by palpation after the patient is properly positioned.Cleaning always starts from the chosen site of approach in circles and then away from the site. Allow time for the cleaning solution to dry. In the spinal kit, the drape placement is on the patients back to isolate the access area. Local anesthetic (usually about 1 mL of 1% lidocaine) is used for skin infiltration, and a wheal is created at the site of access chosen, either midline or paramedian. The needle traverses the skin, followed by subcutaneous fat. As the needle courses deeper, it engages the supraspinous and interspinous ligaments; the practitioner notes this as increased tissue resistance. The practitioner approaches the ligamentum flavum, and this would present like a pop. On popping through this ligament is the approach to the epidural space, which is the point of placement for epidurally administered medications and catheters. This also presents the point where the loss of resistance is felt to the injection of saline or air. For spinal anesthesia, the clinician proceeds with needle insertion until penetration of the dura-subarachnoid membranes, which is signaled by free-flowing CSF. It is at this point that the administration of spinal medication takes place. For the paramedian approach, the skin wheal from the local anesthetic is placed about 2 cm from the midline, and the spinal needle advances at an angle toward the midline. In this approach, the supraspinous and interspinous ligaments are usually not encountered. Hence, there is little resistance encountered until reaching the ligamentum flavum.
|
| Comparator Agent |
TIVA |
group after shifting the patient inside OT, 18 G Intracath will be secured.
Patients will be monitored with five lead electrocardiography (ECG), pulse oximetry, end-tidal
carbon dioxide, temperature and non-invasive blood pressure. Patients will be anaesthetized
using Inj Glycopyrolate (0.2-0.4 mg/kg), inj midazolam (0.05 mg/kg) , inj propofol (2 mg/kg),
inj fentanyl (1 mcg/kg), inj Ketamine (2 mg/kg) intra operative oxygen saturation maintained
99% throughout procedure. Primarily Standard monitoring will be used during anaesthesia and
surgery by Non-invasive blood pressure (NIBP), Invasive Blood Pressure (IBP), pulse
oximetry, Respiratory Rate (RR). SpO2, heart rate and mean arterial pressures will be recorded
before operation and every 5 min for the first 30 mins and then every 30 mins until the end of
the surgery. The anesthesia time (the time from induction of anesthesia to the end of surgery
when the inhalation agent was discontinued), emergence time (the time from the end of surgery
to opening the eyes on calling the patient’s name), a delayed anaesthetic emergence (defined as
20 min elapsing from the end of surgery to exiting the operating theatre), or all will also be
noted. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients willing to participate in the study
2) Patient age 40-75 years
3) ASA grade III
4) Scheduled for high dose rate (HDR) intracavitary brachytherapy
5) Diagnosed with FIGO stage IIB-IIIB carcinoma cervix. |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate in the study
2) Patients who has bleeding tendencies
3) Pregnant females
4) Patients with contraindications to spinal/epidural or general anaesthesia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TIVA is better than sub arachnoid block in Post op pain management for 48 hours in brachytherapy patients.
|
TIVA is better than sub arachnoid block in Post op pain management for 48 hours in brachytherapy patients.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic stability
To study the side effects and complications during the postoperative period.
Post operative surgeon vs patients satisfaction. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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 2 |
|
Date of First Enrollment (India)
|
23/04/2026 |
| 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="0"
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
|
TIVA is better alternative to subarachnoid block in patients of brachytherapy in cervical cancer. It is a randomized double blinded study for a 2 year period for patients posted for brachytherapy who will be receiving subarachnoid block or TIVA . The assessment of Intra op and post operative pain along with the comparison of hemodynamic parameters during intraoperative and postoperative period will be done.
|