| CTRI Number |
CTRI/2024/04/066447 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nerve block versus ketamine gargle for sore throat prevention |
|
Scientific Title of Study
|
Comparison of Ultrasound-guided Superior laryngeal nerve block with Ketamine gargle for prevention of sore throat after endotracheal intubation: A comparative, single-blinded randomized controlled 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 |
Abhishek Vishwakarma |
| Designation |
Junior Resident(Academic) |
| Affiliation |
indira gandhi institute of medical sciences, patna |
| Address |
Department of Anesthesiology and Critical Care Medicine, Neuro OT Complex, First floor, Ward block, IGIMS, Patna, Sheikhpura, Patna-800014, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9102858408 |
| Fax |
|
| Email |
abhishekrims007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod kumar Verma |
| Designation |
Professor |
| Affiliation |
indira gandhi institute of medical sciences, patna |
| Address |
Department of Anesthesiology and Critical Care Medicine, Neuro OT Complex, First floor, Ward block, IGIMS, Patna, Sheikhpura, Patna-800014, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
8292000111 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Vishwakarma |
| Designation |
Junior Resident(Academic) |
| Affiliation |
indira gandhi institute of medical sciences, patna |
| Address |
Department of Anesthesiology and Critical Care Medicine, Neuro OT Complex, First floor, Ward block, IGIMS, Patna, Sheikhpura, Patna-800014, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9102858408 |
| Fax |
|
| Email |
abhishekrims007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira gandhi institute of medical sciences,Patna,Bihar-800014, India |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical SciencesPatna Biha |
| Address |
Department of Anesthesiology and Critical Care Medicine, Neuro OT Complex, First floor, ward block, IGIMS, Patna |
| Type of Sponsor |
Government 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 Abhishek Vishwakarma |
Indira Gandhi Institute of Medical Sciences, Patna |
Department of Anesthesiology And Critical Care Medicine, First Floor, Neuro OT Complex, Ward block, IGIMS Patna, Bihar
Patna
BIHAR |
9102858408
abhishekrims007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine gargle |
Group KG will receive 1mg/kg ketamine in 30ml Normal saline 10 minutes before induction and to be gargled for 1 minute |
| Intervention |
Ultrasound-guided Superior laryngeal nerve block |
Group SLNB will receive USG guided bilateral superior laryngeal nerve block with injection Ropivacaine 0.25% 2ml each side in operation theatre after intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients of ASA 1 & 2
Patients posted for elective surgery under general anesthesia
Patients willing to participate |
|
| ExclusionCriteria |
| Details |
patient refused to participate
allergy to local anesthetics
infection at the site of intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative sore throat(Grade≥2) after nerve block and ketamine gargle after endotracheal intubation. |
At the time of extubation (0hr)
In the ward(2hr, 6hr,12hr, 24hr) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of severity of post operative sore throat
2. Comparison of incidence of cough immediately after end of surgery
3. Comparison of hemodynamic stability between two groups.
4. Observe the incidence of side effects |
At the time of extubation (0hr)
In the ward(2hr, 6hr,12hr, 24hr) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/05/2024 |
| 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
|
Postoperative sore throat is frequently observed as a complication following extubation in patients undergoing general anesthesia with tracheal intubation. Most cases of post-operative sore throat usually resolve on their own, but it can also contribute to patient discomfort eventually extending hospitalization duration, and potentially impacting the mortality rates.
Superior laryngeal nerve blocks have already been proven to be effective in anesthetizing the larynx for airway manipulation and pain management. Moreover, the use of ultrasound-guided nerve blocks, known for their increased success rates due to visualization, is comparatively less time-consuming and associated with fewer complications.
Ketamine gargle has been proven to control postoperative sore throats by blocking various pain-related receptors like N-methyl-D-aspartate receptors in peripheral nerves and exerting agonistic effects on opioid receptors within the mucosa of the oral and upper respiratory tract.
We hypothesized superior laryngeal nerve block ameliorates the incidence and severity of postoperative sore throat better than ketamine gargle.
The primary objective of our study is to compare the incidence of postoperative sore throat (Grade≥2) after superior laryngeal nerve block and ketamine gargle in patients undergoing endotracheal intubation under general anesthesia.
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