Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
Primary Purpose
Sore Throat
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
saline 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Sore Throat
Eligibility Criteria
Inclusion Criteria:
- Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
- Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.
Exclusion Criteria:
- A history of preoperative sore throat.
- Upper respiratory tract illness
- Potentially difficult airway
- Patients with history of neck, respiratory or digestive tract pathology
- Chronic smokers
- Using steroid within the last 48 hour
- Pregnant women
Sites / Locations
- Omar Soliman
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dexmedetomidine
Ketamine
Saline placebo
Arm Description
75 µg dexmedetomidine soaked pharyngeal pack
50 mg ketamine soaked pharyngeal pack
20 ml 0.9% saline soaked pharyngeal pack
Outcomes
Primary Outcome Measures
Incidence of postoperative sore throat (POST)
On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
Secondary Outcome Measures
Postoperative nausea and vomiting (PONV) score
PONV score was assessed and documented using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; 4 mg IV ondansetron for occurred nausea & vomiting.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955158
Brief Title
Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
Official Title
Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).
Detailed Description
A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.
1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and & endotracheal tube (ETT).
2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
75 µg dexmedetomidine soaked pharyngeal pack
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
50 mg ketamine soaked pharyngeal pack
Arm Title
Saline placebo
Arm Type
Experimental
Arm Description
20 ml 0.9% saline soaked pharyngeal pack
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Intervention Type
Other
Intervention Name(s)
saline 0.9%
Other Intervention Name(s)
Normal saline
Intervention Description
20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Primary Outcome Measure Information:
Title
Incidence of postoperative sore throat (POST)
Description
On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV) score
Description
PONV score was assessed and documented using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; 4 mg IV ondansetron for occurred nausea & vomiting.
Time Frame
2 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.
Exclusion Criteria:
A history of preoperative sore throat.
Upper respiratory tract illness
Potentially difficult airway
Patients with history of neck, respiratory or digestive tract pathology
Chronic smokers
Using steroid within the last 48 hour
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Omar makram
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omar Soliman
City
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12066737
Citation
Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
Results Reference
background
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Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
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