Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607885303995 Date of Registration: 06/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Lidocaine-soaked pharyngeal packing during nasal surgeries for post operative sore throat: a randomized comparative study.
Official scientific title Dexmedetomidine versus Lidocaine-soaked pharyngeal packing during nasal surgeries for post operative sore throat: a randomized comparative study.
Brief summary describing the background and objectives of the trial Pharyngeal packing is widely used in head and neck surgeries after induction of anesthesia. It prevents aspiration and ingestion of fluid, blood, or debris during surgery and therefore reduces the risk of post-operative respiratory complications as well as nausea and vomiting. Pharyngeal pack increases the risk of mucosal damage during the placement of the pack and Postoperative sore throat (POST) is the commonest patient complaint. In this study we will investigate the effect of pharyngeal packing soaked with Dexmedetomidine Versus Lidocaine for postoperative sore throat in Nasal surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/06/2026
Actual trial start date
Anticipated date of last follow up 20/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 135
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine pharyngeal packs 75 µg dexmedetomidine diluted in 20 ml 0.9% saline). after intubation till end of surgery Dexmedetomidine-soaked pharyngeal pack (75 µg dexmedetomidine diluted in 20 ml 0.9% saline). 45
Experimental Group lidocaine pharyngeal packs 5 ml of 2% lidocaine diluted in 20 ml 0.9% saline after intubation till end of surgery Lidocaine-soaked pharyngeal pack (5 ml of 2% lidocaine diluted in 20 ml 0.9% saline). 45
Control Group saline pharyngeal packs 20 ml of 0.9% normal saline after intubation till end of surgery saline-soaked pharyngeal pack 45 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 18–60 years • ASA physical status I or II • Undergoing nasal surgery under general anesthesia • No significant laryngotracheal disease • Patient refusal • Pregnancy • Diabetes mellitus • Difficult airways, neck pathology, or GERD. • Malignant nasal disease. • Recent use of systemic or topical sore throat agents. • Regular smokers (Regular smokers are individuals who have smoked at least one cigarette per day for the past 30 days or more). • Allergic to study medications. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/06/2026 institutional review board Ain Shams university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Abbasia Cairo Egypt cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of Postoperative sore throat (POST)will be assessed at PACU using a numeric scale that grades the severity of sore throat pain as follow: • 0: No sore throat • 1: Mild sore throat (complaint only on direct questioning) • 2: Moderate sore throat (complaint reported spontaneously) • 3: Severe sore throat associated with hoarseness or voice change 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively .
Secondary Outcome • Incidence of postoperative cough 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively
Secondary Outcome post operative nausea and vomiting 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively
Secondary Outcome • Total postoperative 24 hours analgesia consumption. 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals al abassya street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Reham Mustafa Hashim principal investigator. Faculty of Medicine El demerdash hospital . Ain Shams university. Abassia cairo 11517 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor no sponsor Abbasia cairo Egypt no sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham M. Hashim dr_reham80@yahoo.com 01003072065 Abbasia
City Postal code Country Position/Affiliation
cairo Egypt assistant professor of anesthesia Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Aya Bayoumy Aya.ali@med.asu.edu.eg 01008085693 abbasia
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Public Enquiries Azza M. Youssef azzalotfy@med.asu.edu.eg 01003574518 abbasia
City Postal code Country Position/Affiliation
cairo Egypt assistant professor of anesthesia Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data collected during the study will be available upon request to the principle investigator. Access to data will be granted for scientifically sound research proposal in accordance with institutional policies. Data will be available after publication of the primary study results. Informed Consent Form Three months duration starting 20 June. Inclusion Criteria: • Age 18–60 years • ASA physical status I or II • Undergoing nasal surgery under general anesthesia • No significant laryngotracheal disease Exclusion Criteria: • Patient refusal • Pregnancy • Diabetes mellitus • Difficult airways, neck pathology, or GERD. • Malignant nasal disease. • Recent use of systemic or topical sore throat agents. • Regular smokers (Regular smokers are individuals who have smoked at least one cigarette per day for the past 30 days or more). • Allergic to study medications.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 27/06/2026 to clarify the intervention groups Experimental Group, dexmedetomidine pharyngeal packs, 75 µg dexmedetomidine diluted in 20 ml 0.9% saline)., after intubation till end of surgery, Dexmedetomidine-soaked pharyngeal pack (75 µg dexmedetomidine diluted in 20 ml 0.9% saline)., 45,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 27/06/2026 to clarify the intervention groups Experimental Group, placing pharyngeal packs, 5 ml of 2% lidocaine diluted in 20 ml 0.9% saline, after intubation till end of surgery, Lidocaine-soaked pharyngeal pack (5 ml of 2% lidocaine diluted in 20 ml 0.9% saline)., 45, Experimental Group, lidocaine pharyngeal packs, 5 ml of 2% lidocaine diluted in 20 ml 0.9% saline, after intubation till end of surgery, Lidocaine-soaked pharyngeal pack (5 ml of 2% lidocaine diluted in 20 ml 0.9% saline)., 45,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 27/06/2026 to clarify the intervention groups Control Group, placing pharyngeal packs, 20 ml of 0.9% normal saline , after intubation till end of surgery, saline-soaked pharyngeal pack , 45, Placebo Control Group, saline pharyngeal packs, 20 ml of 0.9% normal saline , after intubation till end of surgery, saline-soaked pharyngeal pack , 45, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/06/2026 to identify funding source no funding , Abassia , cairo, 11517, Egypt, Self Funded, Dr Reham Mustafa Hashim principal investigator. Faculty of Medicine El demerdash hospital . Ain Shams university., Abassia , cairo, 11517, Egypt, Self Funded,