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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201855749323 Date of Approval: 10/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between Combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery
Official scientific title Comparison between Combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery
Brief summary describing the background and objectives of the trial • Outcome measures: Primary outcome: Comparison between efficacy of the two techniques in optimizing intraoperative surgical field using the average category scale(ACS). Secondary outcome: 1) The HR and MAP will be measured at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. 2) Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs. 3) Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded. 4) The total dose of additional hypotensive agent (phentolamine) requirements. 5) Duration of anesthesia and surgery will be obtained. 6) Pain intensity will be evaluated with a 10-cm VAS (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively. The time to first rescue pain medication and analgesic requirements will be assessed.
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 Education /Training
Anticipated trial start date 15/04/2021
Actual trial start date 30/12/2021
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date 05/04/2023
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Recruiting
Publication URL Scopus.com
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral sphenopalatine ganglion block mix of 2 ml lidocaine 2% and bupivacaine 0.5% for bilateral sphenopalatine ganglion block for each side immediately after induction of general anesthesia, bilateral local nasal nerve block will be done by sphenopalatine ganglion block which will be done via a transoral approach immediately after induction of general anesthesia, bilateral local nasal nerve block will be done by sphenopalatine ganglion block which will be done via a transoral approach using 2ml of a mixture of lidocaine (2%) and bupivacaine (0.5%) for each side. The ganglion will be blocked at the greater palatine foramen. 35
Control Group dexmedetomidine will receive 1 µg/kg dexmedetomedine in 10 minutes before induction of anesthesia, followed by 0.5-1 µg/kg/hour during maintenance of anesthesia. will receive 1 µg/kg dexmedetomedine in 10 minutes before induction of anesthesia, followed by 0.5-1 µg/kg/hour during maintenance of anesthesia. will receive 1 µg/kg dexmedetomedine in 10 minutes before induction of anesthesia, followed by 0.5-1 µg/kg/hour during maintenance of anesthesia. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: 1) Patients of ASA I or ASA II physical status. 2) Patients with age 18-65 years. Exclusion Criteria: 1) Patients with physical status ASA III, IV. 2) Known allergic reactions to local anesthetics. 3) Patients with history for cerebrovascular or coronary insufficiency. 4) Patients with infection at the block site. 5) Patients with coagulopathy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 04/04/2021 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparison between efficacy of the two techniques in optimizing intraoperative surgical field using the average category scale(ACS). At the commencement of surgery and at regular 15-minute intervals the anaesthetist prompted the surgeon for a surgical field assessment. Surgical field will be assessed using the average category scal
Secondary Outcome 1) The HR and MAP will be measured at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. 2) Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs. 3) Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded. 4) The total dose of additional hypotensive agent (phentolamine) requirements. 5) Duration of anesthesia and surgery will be obtained. 6) Pain intensity will be evaluated with a 10-cm VAS (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively. The time to first rescue pain medication and analgesic requirements will be assessed.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moustafa Atef Moustafa Hamouda Nasr street, Awwal Abbas, Nasr city Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Atef Moustafa Hamouda Nasr street, Awwal Abbas, Nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Moustafa Atef Moustafa Hamouda moustafaatef.13b@gmail.com +201061123460 Nasr street, Awwal Abbas, Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Rehab Abdelfattah rehab.fattah2002@gmail.com +201110108610 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Eman Aboseif eman-aboseif@hotmail.com +201022604863 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of anesthesia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Statistical Analysis Plan Following publication Any purpose
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