Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery

• ClinicalTrials.gov Identifier: NCT04955158
• Recruitment Status: Completed
• First Posted: July 8, 2021
• Last Update Posted: April 13, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Omar Makram Soliman, Assiut University

Tracking Information

• First Submitted Date: July 1, 2021
• First Posted Date: July 8, 2021
• Last Update Posted Date: April 13, 2023
• Actual Study Start Date: August 19, 2021
• Actual Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 4, 2021)

Incidence of postoperative sore throat (POST) [ Time Frame: 24 hour after surgery ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 4, 2021)

Postoperative nausea and vomiting (PONV) score [ Time Frame: 2 hours postoperative ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Sore Throat

Intervention

• Drug: Dexmedetomidine
  75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
  Other Name: Precedex
• Drug: Ketamine
  50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
  Other Name: ketalar
• Other: saline 0.9%
  20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
  Other Name: Normal saline

Study Arms

• Experimental: Dexmedetomidine
  75 µg dexmedetomidine soaked pharyngeal pack
  Intervention: Drug: Dexmedetomidine
• Experimental: Ketamine
  50 mg ketamine soaked pharyngeal pack
  Intervention: Drug: Ketamine
• Experimental: Saline placebo
  20 ml 0.9% saline soaked pharyngeal pack
  Intervention: Other: saline 0.9%

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 11, 2023): 143
• Original Estimated Enrollment (submitted: July 4, 2021): 120
• Actual Study Completion Date: February 15, 2023
• Actual Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04955158
• Other Study ID Numbers: 17101486
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Omar Makram Soliman, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Omar Soliman, MD; Omar makram

• PRS Account: Assiut University
• Verification Date: April 2023