NCT05714540

Brief Summary

The aim of this study is to compare the effect of ketamine or magnesium sulphate soaked throat pack on the incidence and severity of post operative sore throat as a primary outcome, post operative nausea and vomiting as a secondary outcome following elective nasal surgery under general anesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 27, 2023

Last Update Submit

July 6, 2023

Conditions

Sore-throatNasopharyngeal PackNasal SurgeryNausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

  • post operative sore throat

    24 hours

Secondary Outcomes (1)

  • nausea and vomiting

    24 hours

Study Arms (3)

Control group

PLACEBO COMPARATOR

The patients will receive 20 ml 0.9% saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and endotracheal intubation .

Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%

ketamine group

ACTIVE COMPARATOR

The patients will receive ketamine soaked 50 mg ketamine in 20 ml normal saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT insertion

Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%

Magnesium group

ACTIVE COMPARATOR

The patients will receive 20 mg/kg magnesium sulfate soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT

Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%

Interventions

Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%DRUG

The Effect of Oropharyngeal Pack Soaked with Ketamine or Magnesium Sulphate on Post Operative Sore Throat after Nasal Surgeries

Control groupMagnesium groupketamine group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study will include 90 adult patients of American Society of Anesthesiologists (ASA) physical status I and II, in the age group of 18 to 60 years of age, of either sex, who will be scheduled for elective nasal surgery (e.g. unilateral or bilateral functional endoscopic sinus surgery, sub mucousal resection, septorhinoplasty , polypectomy) under general anesthesia with endotracheal intubation, having a Mallampatti Grades of I and II and those who are willing to give informed consent.

You may not qualify if:

  • History of recent respiratory tract infection or sore throat , anticipated difficult airway, known allergy to study drug, and preoperative use of analgesics such as non-steroidal anti-inflammatory drugs or opioids, Patients who required more than one attempt for tracheal intubation, or who will need tracheal intubation of \<60 minutes or\>300 minutes will be eliminated from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine beni Suef university

Banī Suwayf, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

PharyngitisPostoperative Nausea and Vomiting

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Jehan Mohamed Mohamed, MD

CONTACT

00201110269572jehanmohamed1510@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jehan Mohammed Mohammed Abdelghany

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 6, 2023

Study Start

February 15, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)