CTRI Number |
CTRI/2021/04/032508 [Registered on: 01/04/2021] Trial Registered Prospectively |
Last Modified On: |
01/04/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Other (Specify) [Randomized Control Trial] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Efficacy of preoperative Vitamin C and combination of Vitamin C, Vitamin D and Zinc for post operative sore throat in patients undergoing elective surgeries under general anaesthesia at Pravara Rural Hospital, Loni. |
Scientific Title of Study
|
Efficacy of Preoperative Vitamin C and Combination of Vitamin C, Vitamin D and zinc for postoperative sore throat in Patients undergoing elective Surgeries under General Anaesthesia at Pravara Rural Hospital, Loni. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pimparkar Pranjali Vijay |
Designation |
PG Resident |
Affiliation |
Rural Medical College, Loni, Ahmednagar |
Address |
PG resident, Department of Anaesthesia and Critical Care, Rural Medical College, Loni, Ahmednagar.
Ahmadnagar MAHARASHTRA 413736 India |
Phone |
9422229400 |
Fax |
|
Email |
pvpimparkar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Akshaya N Shetti |
Designation |
Professor |
Affiliation |
Rural Medical College, Loni, Ahmednagar |
Address |
Professor, Department of Anaesthesiology and Critical Care, Rural Medical College, Loni.
Ahmadnagar MAHARASHTRA 413736 India |
Phone |
7507807673 |
Fax |
|
Email |
aksnsdr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pimparkar Pranjali Vijay |
Designation |
PG Resident |
Affiliation |
Rural Medical College, Loni, Ahmednagar |
Address |
PG resident, Department of Anaesthesia and Critical Care, Rural Medical College, Loni, Ahmednagar.
Ahmadnagar MAHARASHTRA 413736 India |
Phone |
9422229400 |
Fax |
|
Email |
pvpimparkar@gmail.com |
|
Source of Monetary or Material Support
|
Pravara Institute of Medical Sciences, Loni, Ahmednagar. |
|
Primary Sponsor
|
Name |
Pravara Institue Of Medical Sciences |
Address |
Pravara Institute of Medical Sciences, Tal Rahata, Loni, Ahmednagar |
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 Pranjali Vijay Pimparkar |
Pravara Rural Hospital |
Department Of Anesthesiology and Critical Care,Pravara Rural Hospital, Pravara Institue of Medical Sciences, Loni, Tal. Rahata, Ahmednagar Ahmadnagar MAHARASHTRA |
9422229400
pvpimparkar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee UG/PG RMC, PIMS DU |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Administration of combination of Vitamin C, Vitamin D and Zinc. |
Patient will recieve combination of vitamin C, Vitamin D and Zinc one night prior to surgery and on the day of the procedure 30 minutes prior to administration of general anesthesia. And after the extubation patient will be observed for the incidence of post operative sore throat.
|
Intervention |
Administration of Vitamin C preoperatively |
Patient will recieve tab vitamin C one night prior to surgery and on the day of the procedure 30 minutes prior to administration of general anesthesia. And after the extubation patient will be observed for the incidence of post operative sore throat. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1) All patients willing to give consent for participation in the study.
2) All patients aged 18 years to 65 years undergoing elective surgeries under general anesthesia lasting for more than 1 hour and less than 6 hours.
3) Patients graded ASA-I and ASA- 2.
|
|
ExclusionCriteria |
Details |
1) Parents not willing to give consent for participation in the study.
2) Smokers, Pregnant females and patients with recent history of Upper respiratory Tract Infection and Zinc Allergies.
3) Patients having Mallampatti grade > 2.
4) More than 1 Attempt of intubation and Traumatic intubation.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Decreased incidence of post operative sore throat with vitamin C, Vitamin D and Zinc |
Immediately after extubation, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 24 hours. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mean Duration of Laryngoscopy (Seconds) |
At the time of Induction |
Number of Intubation Attempts |
At the time of laryngoscopy |
Mean duration of anaesthesia and surgery |
From start of procedure till extubation of patient |
Cormack Lehan Grading |
During Laryngoscopy |
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
05/04/2021 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
A randomized control trial will be carried out at the department of Anesthesiology of Rural Medical
College, Loni. All patients who will fulfill inclusion and exclusion criteria
at Pravara Rural
Hospital (PRH),
Loni will be included as study subjects.
Pertinent data will be collected using a
pre-validated and pre-tested study
tool, from all study subjects,
who will receive Vitamin C and combination of Vitamin C, Vitamin D and Zinc as
mentioned below, during a study period
of March 2021 to February 2022.
Group
A- All patients aged 18 years to 65 years
undergoing surgeries under general anesthesia who will receive Tablet Vitamin C.
Group
B- All patients aged 18 years to 65 years
undergoing surgeries under general anesthesia who will receive a combination of
Vitamin C, Vitamin D and Zinc.
CONSENT: The patients will be explained in
detail regarding the anaesthetic procedure and the study. Written and verbal
consent will be taken for the procedure, as well as for his/her inclusion in
the proposed study.
PREPARATION: As per routine protocol of the
institution, the patients will be thoroughly evaluated by a pre-anaesthetic
check-up with general, physical and systemic examination on the evening prior
to the proposed surgery. The severity of POST was explained to patients graded
from 0 to 3, with 0 corresponding to no sore throat and 3 to severe sore throat
with change of voice, hoarseness and severe throat pain. All the patients will
receive vitamin C and or combination of Vitamin C, Vitamin D and Zinc 1 day
prior to surgery at night. Patients will be fasted for a period of 6 hours
pre-operatively.
PROCEDURE: On the day of surgery,
patients will receive vitamin C and or combination of Vitamin C, Vitamin D and
Zinc in preoperative area with instruction to dissolve it in mouth by sucking
on it 30 minutes prior to procedure. Patients will then be shifted to the
operating room and standard monitoring, including electrocardiogram, mean arterial
blood pressure, respiratory rate and oxygen saturation will be started using
multi-para monitors. The anaesthesia machine, breathing circuits, emergency
resuscitation trolley and airway equipment will be kept ready.
All the patients in group A and B will be
given general anesthesia. Premedication IV injection of
Glycopyrrolate(0.008mg/kg), Midazolam(0.04mg/kg) and Fentanyl (1mcg/kg) will be
given. Induction will be done with Inj. Propofol (2 mg/kg) followed by
orotracheal intubation facilitated by Inj. Succinylcholine (2 mg/kg).
Laryngoscopies will be performed by Macintosh blade 3 and 4 to insert
endotracheal tubes of inner diameter 7 to 8.5 mm. The laryngoscopic view will
be graded according to Cormack Lehan Grading. Anaesthesia will be maintained with
Isoflurane and Inj. Vecuronium (0.08 mg/kg) followed by top-ups of 0.01 mg/kg.
Intermittently, every half hour cuff pressure will be measured and adjusted to
30 cm of water. Intra operatively use of steroids and anti-inflammatory drugs
was noted. After surgical procedure patient is extubated after reversal with
Inj. Neostigmine (0.05mg/kg) and Inj. Glycopyrrolate (0.01mg/kg) and coughing
or bucking will be noted at the time of emergence.
At the end of the surgery, the patients will
be shifted to the post- anaesthesia care unit, and will receive the same basic
standard of post-operative care.
OBSERVATIONS:
Primary Variable:
An
immediate evaluation for presence and severity sore throat after extubation
(time = 0) and then in postoperative care unit will be done, using a
standardized scale in postoperative care unit. This evaluation will be repeated
at 30 mins, 1 hour, 2 hrs, 4 hrs, 6 hrs and 24 hrs.
GRADE
|
SEVERITY
|
0
|
no sore throat
|
1
|
mild discomfort
(complaints only upon questioning)
|
2
|
moderate sore throat
(complains of his/her own)
|
3
|
severe sore throat (change
in voice, hoarseness and throat pain)
|
Secondary Variables:
·
Mean Duration of Laryngoscopy
(Seconds)
·
No of intubation attempts
·
Mean duration of Anesthesia
(Minutes)
·
Mean Surgery Duration( Minutes)
·
Cormack Lehan Grading:
Grade 1 –– full glottic view
Grade
2 –– only posterior extremity of glottis visible
Grade
3 –– only epiglottis visible
Grade 4 ––
no recognizable structure visible without laryngeal manipulation. |