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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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