| CTRI Number |
CTRI/2025/07/091241 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the anaesthesia management of patients undergoing surgery to treat oesophageal cancer using a technique called IONM (a technique that helps identify the nerve supplying the voice box during surgery). |
|
Scientific Title of Study
|
A prospective observational study of anaesthesia practices in esophageal cancer surgeries with intraoperative nerve monitoring.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4762_Version 1.1 dated 09.05.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Parab |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Parab |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Jadhav |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9975272797 |
| Fax |
|
| Email |
ganuvrush.gj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E Borges Road, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Swapnil Parab |
Tata Memorial Hospital |
Major operation theatre, 2nd floor, Main building, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
2224177000
swapnil.parab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMH Institutional Ethics Committee_I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing elective surgery for oesophagal cancer with IONM |
|
| ExclusionCriteria |
| Details |
1) Emergency surgery
2) Patient not giving consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Intraoperative nerve monitoring (IONM) on the incidence of RLN palsy,
assessed by rate of vocal cord palsy |
Post operative Day 1 to 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the total dose of intravenous propofol administered during the surgery and its effect on time for extubation of trachea after surgery.
|
post operative Day 1 to 3 |
2. to find out the correlation between depth of neuromuscular blockade and amplitude of responses at the time of the nerve stimulation.
|
Intraoperative |
| 3. To find out the effect of IONM on postoperative morbidity and mortality. |
until hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/07/2025 |
| 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="0"
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
|
Surgical esophagectomy is a curative treatment for cancers involving lower and middle
esophagus. During an esophagectomy, injury to the recurrent laryngeal nerve (RLN) is likely due
to the proximity of the nerve to the oesophagus in the trachea-esophageal groove. The recurrent
laryngeal nerve Is a branch of the vagus nerve that provides sensory and motor innervation to the
larynx, including its muscles and structures. Right RLN branches from the vagus nerve around
the T1- T2 level, then loops under the right subclavian artery and moves back up through the
neck. Left RLN arises anteriorly at the arch of the aorta, then loops under the aortic arch and
moves back up through the neck. The RLN innervates all the intrinsic muscles of the larynx,
except for the cricothyroid muscle, which is innervated by the superior laryngeal nerve. RLN
also carries sensations from the laryngeal mucosa on the undersurface of vocal cords and
subglottis. Injury to RLN results in varying grades of nerve dysfunctions and vocal cord palsy.
Following an injury to RLN, adduction of the vocal cord gets affected and the vocal cord remains
in the paramedian position, resulting in the phonatory gap between the two cords. It results in the
hoarseness of the voice, ineffective cough and increases the possibility of aspiration of food
contents in the lower airway. It significantly affects postoperative morbidity and mortality
following esophageal surgery.
The current incidence of RLN injury during esophageal surgery varies from 5-15%.1 Various
surgical and disease-related factors affect the incidence of RLN following esophagectomy
surgery. RLN injury is more common in tumours involving the upper and middle oesophagus.
McKeown’s esophagectomy carries a higher risk of RLN injury as compared to Ivor-Lewis’s
approach of esophagectomy. Three-field lymphadenectomy (i.e. resection of abdominal,
mediastinal and cervical lymph nodes) carries a higher incidence of RLN injury as compared to
the two-field approach (i.e. resection of abdominal and mediastinal lymph nodes) of
lymphadenectomy during oesophagal surgery.
Intraoperative monitoring of RLN (IONM) helps the surgeons to identify the nerve fibres during
the surgical resection and to preserve them. RLN monitoring during the surgery needs a few
modifications in the anaesthesia techniques- viz. minimal use of muscle relaxant, use of a special
endotracheal tube that carries surface sensors to identify vocal cord movements, limiting the use
of
inhalational anesthetic agents etc. It also involves the active participation of
neurophysiologists during the surgery.
At Tata Memorial Hospital, we conduct nearly 180 esophagectomies every year. IONM is conducted in
suitable case (approximately 25 cases per year). During the surgeries that require IONM, the
neuromuscular blockade is avoided. The depth of anaesthesia is maintained by either inhalational
anaesthesia (up to 1 MAC) or by total intravenous anaesthesia using intravenous propofol. A special
endotracheal tube (endotracheal tube with surface sensors on its surface to detect vocal cord movements)
is used for these surgeries.
Hence, we wish to conduct a prospective observational study to find out the anaesthesia practices
during IONM and their effects on the incidence of RLN injury following esophagectomy
surgeries. |