A Phase 3 interventional study of Dexmedetomidine and Ketamine in Sore Throat, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
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).
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.
252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.
This study's enrollment of 143 is close to the median of 144 across 209 interventional studies indexed under Pharyngitis.
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Exclusion Criteria:
75 µg dexmedetomidine soaked pharyngeal pack
Drug: Dexmedetomidine
50 mg ketamine soaked pharyngeal pack
Drug: Ketamine
20 ml 0.9% saline soaked pharyngeal pack
Other: saline 0.9%
75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Also known as: Precedex
50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Also known as: ketalar
20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Also known as: Normal saline
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.
Time frame: 24 hour after surgery
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.
Time frame: 2 hours postoperative
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Assiut University