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
|Condition or disease||Intervention/treatment||Phase|
|Sore Throat||Drug: Dexmedetomidine Drug: Ketamine Other: saline 0.9%||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
75 µg dexmedetomidine soaked pharyngeal pack
75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Other Name: Precedex
50 mg ketamine soaked pharyngeal pack
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
- 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.
- 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.
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
|Contact: Omar Soliman, MDemail@example.com|
|Assuit, Egypt, Assuit universi|
|Contact: Omar Soliman 01101266040 firstname.lastname@example.org|
|Principal Investigator:||Omar Soliman, MD||Omar makram|