| CTRI Number |
CTRI/2025/03/083694 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of blood pressure, heart rate and pain suppression ability of two different local anaesthetic drugs i.e. lidocaine and levobupivacaine used in patients undergoing pituitary tumor surgeries via nasal route. |
|
Scientific Title of Study
|
Comparison of hemodynamic stability and analgesic efficacy of topical intranasal
lidocaine versus levobupivacaine in patient undergoing endoscopic
binostril transnasal transsphenoidal resection of pituitary tumour surgeries: A
prospective randomized double blind study. |
| 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.Shameer imam |
| Designation |
DM First year (Senior Resident) |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur |
| Address |
ROOM NO.208 SABARMATI HOSTEL OPP BURGER FARM MAHATMA GANDHI MEDICAL COLLEGE JAIPUR
Department of Neuroanaesthesia fourth floor SRMC building MAHATMA GANDHI MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
202002
India |
| Phone |
8127553526 |
| Fax |
|
| Email |
shamimam00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sunita Sharma |
| Designation |
Professor and Head Of Department |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur |
| Address |
Department of Neuroanaesthesia fourth floor SRMC building MAHATMA GANDHI MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
302022
India |
| Phone |
|
| Fax |
|
| Email |
drsunitakhs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sunita Sharma |
| Designation |
Professor and Head Of Department |
| Affiliation |
Mahatma gandhi medical college and hospital jaipur |
| Address |
Department of Neuroanaesthesia fourth floor SRMC building MAHATMA GANDHI MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
302022
India |
| Phone |
|
| Fax |
|
| Email |
drsunitakhs@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital Jaipur RIICO Institutional Area,
Sitapura,Tonk Road,
Jaipur-
pin code (302 022 )
(Rajasthan)
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital Jaipur |
| Address |
RIICO Institutional Area,Sitapura,
Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA |
| 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 Shameer Imam |
Mahatma Gandhi Medical College and Hospital Jaipur |
4th floor Sri Ram Cancer Center
OT Complex Department of Neuroanesthesia
Jaipur
RAJASTHAN |
8127553526
shamimam00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levobupivacaine group |
Patients undergoing the study were randomly assigned to receive intranasal packing with 15 mL of 0.5% levobupivacaine combined with 60mg of ephedrine (2 mL) Prior to the surgical procedure, the study drug vial was provided to the scrub nurse by the principal investigator. The scrub nurse then prepared the packing solution by mixing the study drug with 60 mg of ephedrine (2 mL) in a sterile manner. Subsequently, six standard-sized packing gauzes were thoroughly soaked in the prepared solution and carefully inserted into both nasal cavities immediately after the patient was intubated. The intranasal gauze packs remained in place for a duration of 20 minutes, coinciding with the time taken for the patient to be prepped and draped for the surgical procedure. After this period, the packs were removed to facilitate the commencement of the operation |
| Comparator Agent |
lidocaine group |
Patients undergoing the study were randomly assigned to receive intranasal packing with 15 mL of 1.5% lidocaine combined with 60mg of ephedrine (2 mL) Prior to the surgical procedure, the study drug vial was provided to the scrub nurse by the principal investigator. The scrub nurse then prepared the packing solution by mixing the study drug with 60 mg of ephedrine (2 mL) in a sterile manner. Subsequently, six standard-sized packing gauzes were thoroughly soaked in the prepared solution and carefully inserted into both nasal cavities immediately after the patient was intubated.
The intranasal gauze packs remained in place for a duration of 20 minutes, coinciding with the time taken for the patient to be prepped and draped for the surgical procedure. After this period, the packs were removed to facilitate the commencement of the operation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 to 65 years.
2. Both male and female patients.
3. American Society of Anesthesiologists physical class 2 or 3.
4. Scheduled for endoscopic binostril transnasal transsphenoidal (TNTS) surgery.
5. Diagnosis of sellar or suprasellar tumors.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to provide informed consent.
2. Preoperative cerebrospinal fluid leak.
3. Known allergy to local anesthetic agents.
4. Preoperative cardiac arrhythmias.
5. History of seizure disorders.
6. Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic changes between both groups and report adverse effects if any.
|
3 min,(Post tracheal intubation),At insertion of endoscope,3 min. later, At start of mucosal dissection,1 min/2min/3min/4min/5min,10 min,20 min,30 min,40 min,50 min,60 min,1hr 30 min,2 hr,2hr 30 min,3hr.,At tracheal extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative bleeding in the surgical field between both groups.
|
Boezaart surgical field Grade 1 ,2,3,4,5 |
| To compare the time to extubation of patients between both groups. |
Time to be recorded from the time of stopping the inhalation agent till the removal of endotracheal tube |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/04/2025 |
| 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="1"
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
|
Type of Study
– Hospital based prospective randomized double blind study.
Period of Study – 18
months from the day of approval.
Place of study – Dept.of NeuroAnaesthesiology, Mahatma
Gandhi Medical College
and Hospital, Jaipur Procedure/Method:
Patients undergoing
the study were randomly assigned to receive intranasal packing with either 15
mL of 1.5% lidocaine or 15 mL of 0.5% levobupivacaine, both combined with 60mg
of ephedrine (2 mL). This randomization process was carried out through
stratified block randomization, ensuring an equal distribution of study drugs.
The allocation was conducted by a biostatistician who was independent of the
study using the Statistical Analysis System software. The sequence of
randomization was then communicated to the pharmacist responsible for packaging
the drugs. These drugs were carefully packaged in amber colored bottles, which
were labeled numerically in accordance with the randomization sequence.
To maintain
blinding throughout the study, neither the patients nor the investigators were
aware of the assigned treatment. The randomization code was securely kept
confidential in the pharmacy department until it was disclosed at the
conclusion of the study. Prior to the surgical procedure, the appropriate study
drug vial was provided to the scrub nurse by the principal investigator. The
scrub nurse then prepared the packing solution by mixing the study drug with 60
mg of ephedrine (2 mL) in a sterile manner. Subsequently, six standard-sized
packing gauzes were thoroughly soaked in the prepared solution and carefully
inserted into both nasal cavities immediately after the patient was intubated.
The intranasal
gauze packs remained in place for a duration of 20 minutes, coinciding with the
time taken for the patient to be prepped and draped for the surgical procedure.
After this period, the packs were removed to facilitate the commencement of the
operation. Throughout this entire process, strict adherence to blinding
protocols was maintained to prevent any bias in the study outcomes. |