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.
- Conditions
- Other specified disorders of middle ear and mastoid in diseases classified elsewhere,
- Registration Number
- CTRI/2021/04/032508
- Lead Sponsor
- Pravara Institue Of Medical Sciences
- Brief Summary
A randomized control trial will be carried out at the department of Anesthesiology of Rural MedicalCollege, Loni. All patients who will fulfill inclusion and exclusion criteriaat Pravara RuralHospital (PRH),Loni will be included as study subjects.Pertinent data will be collected using apre-validated and pre-tested studytool, from all study subjects,who will receive Vitamin C and combination of Vitamin C, Vitamin D and Zinc asmentioned below, during a study periodof March 2021 to February 2022.
**GroupA-** All patients aged 18 years to 65 yearsundergoing surgeries under general anesthesia who will receive Tablet Vitamin C.
**GroupB-** All patients aged 18 years to 65 yearsundergoing surgeries under general anesthesia who will receive a combination ofVitamin C, Vitamin D and Zinc.
CONSENT: The patients will be explained indetail regarding the anaesthetic procedure and the study. Written and verbalconsent will be taken for the procedure, as well as for his/her inclusion inthe proposed study.
PREPARATION: As per routine protocol of theinstitution, the patients will be thoroughly evaluated by a pre-anaestheticcheck-up with general, physical and systemic examination on the evening priorto the proposed surgery. The severity of POST was explained to patients gradedfrom 0 to 3, with 0 corresponding to no sore throat and 3 to severe sore throatwith change of voice, hoarseness and severe throat pain. All the patients willreceive vitamin C and or combination of Vitamin C, Vitamin D and Zinc 1 dayprior to surgery at night. Patients will be fasted for a period of 6 hourspre-operatively.
PROCEDURE: On the day of surgery,patients will receive vitamin C and or combination of Vitamin C, Vitamin D andZinc in preoperative area with instruction to dissolve it in mouth by suckingon it 30 minutes prior to procedure. Patients will then be shifted to theoperating room and standard monitoring, including electrocardiogram, mean arterialblood pressure, respiratory rate and oxygen saturation will be started usingmulti-para monitors. The anaesthesia machine, breathing circuits, emergencyresuscitation trolley and airway equipment will be kept ready.
All the patients in group A and B will begiven general anesthesia. Premedication IV injection ofGlycopyrrolate(0.008mg/kg), Midazolam(0.04mg/kg) and Fentanyl (1mcg/kg) will begiven. Induction will be done with Inj. Propofol (2 mg/kg) followed byorotracheal intubation facilitated by Inj. Succinylcholine (2 mg/kg).Laryngoscopies will be performed by Macintosh blade 3 and 4 to insertendotracheal tubes of inner diameter 7 to 8.5 mm. The laryngoscopic view willbe graded according to Cormack Lehan Grading. Anaesthesia will be maintained withIsoflurane 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 to30 cm of water. Intra operatively use of steroids and anti-inflammatory drugswas noted. After surgical procedure patient is extubated after reversal withInj. Neostigmine (0.05mg/kg) and Inj. Glycopyrrolate (0.01mg/kg) and coughingor bucking will be noted at the time of emergence.
At the end of the surgery, the patients willbe shifted to the post- anaesthesia care unit, and will receive the same basicstandard of post-operative care.
OBSERVATIONS:
Primary Variable:
Animmediate evaluation for presence and severity sore throat after extubation(time = 0) and then in postoperative care unit will be done, using astandardized scale in postoperative care unit. This evaluation will be repeatedat 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
Grade2 –– only posterior extremity of glottis visible
Grade3 –– only epiglottis visible
Grade 4 ––no recognizable structure visible without laryngeal manipulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 110
-
- All patients willing to give consent for participation in the study.
-
- 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.
-
- Patients graded ASA-I and ASA- 2.
-
- Parents not willing to give consent for participation in the study.
-
- Smokers, Pregnant females and patients with recent history of Upper respiratory Tract Infection and Zinc Allergies.
-
- Patients having Mallampatti grade > 2.
-
- More than 1 Attempt of intubation and Traumatic intubation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Number of Intubation Attempts At the time of laryngoscopy Mean duration of anaesthesia and surgery From start of procedure till extubation of patient Mean Duration of Laryngoscopy (Seconds) At the time of Induction Cormack Lehan Grading During Laryngoscopy
Trial Locations
- Locations (1)
Pravara Rural Hospital
🇮🇳Ahmadnagar, MAHARASHTRA, India
Pravara Rural Hospital🇮🇳Ahmadnagar, MAHARASHTRA, IndiaDr Pranjali Vijay PimparkarPrincipal investigator9422229400pvpimparkar@gmail.com