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Effect of Oropharyngeal Pack Soaked in Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgery

Primary Purpose

Sore-throat, Nasopharyngeal Pack, Nasal Surgery

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore-throat

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of medicine beni Suef universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

ketamine group

Magnesium group

Arm Description

The patients will receive 20 ml 0.9% saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and endotracheal intubation .

The patients will receive ketamine soaked 50 mg ketamine in 20 ml normal saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT insertion

The patients will receive 20 mg/kg magnesium sulfate soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT

Outcomes

Primary Outcome Measures

post operative sore throat

Secondary Outcome Measures

nausea and vomiting

Full Information

First Posted
January 27, 2023
Last Updated
July 6, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05714540
Brief Title
Effect of Oropharyngeal Pack Soaked in Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgery
Official Title
The Effect of Oropharyngeal Pack Soaked With Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgeries: Randomized Controlled Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Postoperative sore throat (POST) is defined as pain, discomfort, or irritation in the throat after general anesthesia and tracheal intubation that worsens with swallowing. Etiological factors playing a significant role in this anesthetic complication are: Size of the endotracheal tube, design and pressure of cuff, the use of nasogastric tubes, lubricants, muscle relaxants, duration of surgery, surgery in and around the oral cavity, trauma arising from laryngoscopy, and use of pharyngeal packs. Pharyngeal packs are commonly used during nasal surgeries to prevent aspiration, tracheal contamination and passage of blood into the stomach. They are disputed to increase the incidence of postoperative sore throat (POST), but surgery in and around the oral cavity necessitates them to soak blood and debris that result as consequence of surgery and decrease post operative nausea and vomiting. Nausea and vomiting are important postoperative complications in all surgical settings and more in nasal surgery due to the presence of blood in the stomach, pain and inflammation of the uvula and throat, and the occasional use of opioids for pain control are all contributing factors. Many interventions can be used to decrease incidence of POST. These include using smaller endotracheal tube size including video laryngoscopy in intubation process, limiting endotracheal cuff pressure and perioperative use of steroids (intravenous, topical or inhaled). Also pharyngeal packs soaked with agents with analgesic effect can be used to decrease post operative sore throat, nausea and vomiting. N methyl D aspartate (NMDA) receptors are present in the central nervous system and also in the peripheral nervous system . These receptors contribute in inflammatory pain. Ketamine and Magnesium sulphate are NMDA antagonist with antinociceptive and anti-inflammatory effect, which may be a possible mechanism in prevention of postoperative sore throat (POST).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore-throat, Nasopharyngeal Pack, Nasal Surgery, Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients will receive 20 ml 0.9% saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and endotracheal intubation .
Arm Title
ketamine group
Arm Type
Active Comparator
Arm Description
The patients will receive ketamine soaked 50 mg ketamine in 20 ml normal saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT insertion
Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
The patients will receive 20 mg/kg magnesium sulfate soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
Intervention Description
The Effect of Oropharyngeal Pack Soaked with Ketamine or Magnesium Sulphate on Post Operative Sore Throat after Nasal Surgeries
Primary Outcome Measure Information:
Title
post operative sore throat
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
nausea and vomiting
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jehan Mohamed Mohamed, MD
Phone
00201110269572
Email
jehanmohamed1510@gmail.com
Facility Information:
Facility Name
Faculty of medicine beni Suef university
City
Banī Suwayf
ZIP/Postal Code
62511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jehan Mohamed Mohamed, MD
Phone
00201110269572
Email
jehanmohamed1510@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Oropharyngeal Pack Soaked in Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgery

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