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Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery

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ClinicalTrials.gov Identifier: NCT04955158
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Omar Makram Soliman, Assiut University

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).

Condition or disease Intervention/treatment Phase
Sore Throat Drug: Dexmedetomidine Drug: Ketamine Other: saline 0.9% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Experimental: Dexmedetomidine
75 µg dexmedetomidine soaked pharyngeal pack
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

Experimental: Ketamine
50 mg ketamine soaked pharyngeal pack
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

Experimental: Saline placebo
20 ml 0.9% saline soaked pharyngeal pack
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04955158


Contacts
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Contact: Omar Soliman, MD 01101266040 omarmakram347@yahoo.com

Locations
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Egypt
Omar Soliman Recruiting
Assuit, Egypt, Assuit universi
Contact: Omar Soliman    01101266040    omarmakram347@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Omar Soliman, MD Omar makram
Publications:
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Responsible Party: Omar Makram Soliman, Lecturer of anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT04955158    
Other Study ID Numbers: 17101486
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents