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.: PACTR201712002865399 Date of Approval: 13/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Deliberate-hypotensve anaesthesia in pediatric sinus endoscopy
Official scientific title Deliberate hypotensve anaesthesia in pediatric sinus endoscopy
Brief summary describing the background and objectives of the trial Eighty pediatric patients aged 8-12 years scheduled for elective nasal surgery under general anesthesia. Patients were classified into two equal groups (40 patients per group) according to study drugs used. Group (I): The patients in this group received remifentanil 0.5 ¿g/kg as loading dose over 10 minutes followed by 0.05-1 ¿g/kg/h as maintenance infusion after induction of anesthesia but before surgery. Group (II): The patients in this group received labetalol 20 mg as loading dose over 10 minutes followed by 0.5-2 ¿g/kg/min as maintenance infusion after induction of anesthesia but before surgery. Measurements: Heart rate, Mean Arterial blood Pressure, Quality of surgical field, duration of surgery, duration of anesthesia, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea, serum creatinine, adverse events and postoperative analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Deliberate hypotensive anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2018
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 01/03/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group (I): The patients in this group received remifentanil 0.5 ¿g/kg as loading dose over 10 min Group (I): The patients in this group received remifentanil 0.5 ¿g/kg as loading dose over 10 min throughout sinus surgery Group (I): The patients in this group received remifentanil 0.5 ¿g/kg as loading dose over 10 min 40
Experimental Group Group (II): The patients in this group received esmolol 20 mg as loading dose over 10 minutes follow Group (II): The patients in this group received esmolol 20 mg as loading dose over 10 minutes followed by 0.05-1 ¿g/kg/min as maintenance infusion after induction of anesthesia but before surgery Group (II): The patients in this group received esmolol 20 mg as loading dose over 10 minutes followed by 0.05-1 ¿g/kg/min as maintenance infusion after induction of anesthesia but before surgery Group (II): The patients in this group received esmolol 20 mg as loading dose over 10 minutes followed by 0.05-1 ¿g/kg/min as maintenance infusion after induction of anesthesia but before surgery. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients aging 8-12 years of both sex with ASA I and II scheduled for elective nasal surgery during general anesthesia. Refusal of patients' guardian to participate in the study, patients with disorder of coagulation, thrombocytopenia, patients on anticoagulant therapy, and patients with congenital heart disease. Figure 1 shows the patients flow diagram. 8 Year(s) 12 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 01/01/2017 Research Ethics Committee, Quality Assurance Unite, Tanta University, faculty of medicine,
Ethics Committee Address
Street address City Postal code Country
algish tanta 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes of this study are the quality of surgical field and changes in the hemodynamic parameters The primary outcomes of this study are the quality of surgical field and changes in the hemodynamic parameters
Secondary Outcome duration of surgery, time to first analgesic request and postoperative complications were the secondary outcomes. duration of surgery, time to first analgesic request and postoperative complications were the secondary outcomes.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Unicersity Hospital Algeish Tanta 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nagat S. Elshmaa Alstat Tanta 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nagat S. Elshmaa Algeish Tanta 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nagat Elshmaa nagat_elshmaa@yahoo.com 00201211865637 Algish
City Postal code Country Position/Affiliation
Tanta 12345 Egypt Asistant professor in Tanta University Hospital
Role Name Email Phone Street address
Public Enquiries Doaaelamrousy Elamrousy doaamoha@yahoo.com 00101222364989 Algish
City Postal code Country Position/Affiliation
Tanta 12345 Egypt Assistant professor in Tanta University Hospital
Role Name Email Phone Street address
Scientific Enquiries Nagat Elshmaa nagat_elshmaa@yahoo.com 00201211865637 Alstat
City Postal code Country Position/Affiliation
Tanta 12345 Egypt Asistant professor in Tanta University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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