Clinical trial

The Effect of Oropharyngeal Pack Soaked With Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgeries: Randomized Controlled Double Blind Study

Name
OPP in nasal surgery
Description
The aim of this study is to compare the effect of ketamine or magnesium sulphate soaked throat pack on the incidence and severity of post operative sore throat as a primary outcome, post operative nausea and vomiting as a secondary outcome following elective nasal surgery under general anesthesia.
Trial arms
Trial start
2023-02-15
Estimated PCD
2023-08-01
Trial end
2023-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
The Effect of Oropharyngeal Pack Soaked with Ketamine or Magnesium Sulphate on Post Operative Sore Throat after Nasal Surgeries
Arms:
Control group, Magnesium group, ketamine group
Size
90
Primary endpoint
post operative sore throat
24 hours
Eligibility criteria
Inclusion Criteria: * The study will include 90 adult patients of American Society of Anesthesiologists (ASA) physical status I and II, in the age group of 18 to 60 years of age, of either sex, who will be scheduled for elective nasal surgery (e.g. unilateral or bilateral functional endoscopic sinus surgery, sub mucousal resection, septorhinoplasty , polypectomy) under general anesthesia with endotracheal intubation, having a Mallampatti Grades of I and II and those who are willing to give informed consent. Exclusion Criteria: * History of recent respiratory tract infection or sore throat , anticipated difficult airway, known allergy to study drug, and preoperative use of analgesics such as non-steroidal anti-inflammatory drugs or opioids, Patients who required more than one attempt for tracheal intubation, or who will need tracheal intubation of \<60 minutes or\>300 minutes will be eliminated from the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-07-07

1 organization

1 product

5 indications

Indication
Sore throat
Indication
Nasal Surgery
Indication
Nausea
Indication
Postoperative