| CTRI Number |
CTRI/2018/04/013011 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reduction of emergence reactions like cough, hypertension after general anaesthesia with intratracheal lignocaine as compared to intratracheal normal saline in endoscopic transsphenoidal pituitary surgery patients |
|
Scientific Title of Study
|
Evaluation of intratracheal lignocaine as compared to normal saline to reduce emergence reactions in the patients undergoing endoscopic transphenoidal pituitary surgery : a double blind randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruhi Mamualiya |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
New Delhi
Department of Neuroanaesthesiology and Critical Care
AIIMS
New Delhi
New Delhi
DELHI
110059
India |
| Phone |
7838823890 |
| Fax |
|
| Email |
ruhimamualiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir Prakash Pandia |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
New Delhi
Department of Neuroanaesthesiology and Critical Care
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
98683978203 |
| Fax |
|
| Email |
pandiamihir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruhi Mamualiya |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
New Delhi
Department of Neuroanaesthesiology and Critical Care
AIIMS
New Delhi
New Delhi
DELHI
110059
India |
| Phone |
7838823890 |
| Fax |
|
| Email |
ruhimamualiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, AIIMS, New Delhi. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
New Delhi |
| 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 |
| Ruhi Mamualiya |
All India Institute of Medical Sciences |
Department of Neuroanaesthesiology and Critical Care
New Delhi
DELHI |
7838823890
ruhimamualiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing endoscopic trans sphenoidal pituitary surgery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine |
Lignocaine is commonly used local anaesthetic drug . In this study we will be using 1 mg/kg of body weight (or 0.05ml/kg of body weight) of 2% lignocaine intratracheally during emergence from anaesthesia to suppress the emergence reactions like coughin and hemodynamic changes |
| Comparator Agent |
Normal saline |
In this study 0.05ml/kg body weight of normal saline will be used intratracheally as control during emergence from general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18 – 65 years of age.
2. ASA grade I & II patients.
3. Patients of Pituitary tumor posted for elective endoscopic transphenoidal surgery for tumor excision
|
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Patients with history of smoking or chronic cough
3. Patients with history of upper respiratory tract infection (URI) in last 8 weeks
4. Patients with bleeding disorders
5. Previous laryngeal or tracheal surgery or pathology
6. Patients with history of gastric reflux
7. Patients with preoperative GCS<15
8. Patients with pulmonary disease, renal, cardiac or hepatic disorders, uncontrolled diabetes
9. Patients with clinical sign of hypothyroidism
10. Patients with BMI > 35kg/mt2
11. Patients with the history of hypertension (controlled or uncontrolled)
12. Patients with upper respiratory tract infection
13. Patients having history of allergic reactions to study drug
Post inclusion exclusion :
1. Need of more than 2 attempts of tracheal intubation or need of bougie for tracheal intubation
2. Patients who can not be extubated and are planned for elective ventilation
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of intratracheal lidocaine on suppressing the cough on emergence from general anesthesia in patients undergoing endoscopic transphenoidal pituitary surgery. |
During emergence from general anesthesia after the end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine effect of intratracheal lignocaine on HR and BP changes
To determine the effect of intratracheal lignocaine on the emergence time, extubation time and recovery time
To determine effect of intratracheal lignocaine on the neurological recovery in the early postoperative period.
To determine effect of intratracheal lignocaine on arterial blood gas (ABG) in the early postoperative period
|
During the maintenance phase and emergence phase of general anesthesia |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/02/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
In this study we will be instilling 2% lignocaine 0.05ml in group L and Normal saline 0.05ml in group NS , 5 minutes before extubation in patients who underwent endoscopic transphenoidal surgery.This type of study have never been done in endoscopic trans sphenoidal surgery patients. We will be determinining the effect of lignocaine in suppressing the cough during emergence from anaesthesia. Preventing cough in this patients is important in these patients to prevent the increase in intracranial pressure post surgery.
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