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.: PACTR201712002826324 Date of Approval: 30/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The utility of remifentanil compared with Nitroglycerin for deliberate hypotensive anaesthesia throughout tympanoplasty. Randomized and Observer-blind
Official scientific title The utility of remifentanil compared with Nitroglycerin for deliberate hypotensive anaesthesia throughout tympanoplasty. Randomized and Observer-blinded clinical trial
Brief summary describing the background and objectives of the trial Background: The purpose of this randomized observer-blinded clinical trial was to evaluate the utility of remifentanil compared with nitroglycerin for deliberate hypotensive anaesthesia throughout tympanoplasty. Methods: Patients planned for elective typanoplasty under general anaesthesia were allocated to receive either intravenous infusion of nitroglycerin 2-5 µg/kg/min (group NTG) , or remifentanil 0.2-0.5 µg /kg/min (group REMI).The primary outcome measures were to keep up MAP between 60 and 70 mmHg with ideal vision of operative site . Results: Both studied agents induced deliberate hypotensive anaesthesia and achieved ideal vision of the surgical site by decreasing bleeding but optimum vision was provided at resonable hypotension (MAP 70¿75) in group REMI however similar situation was provided at MAP 65¿69 mmHg in group NTG. Conclusion: remifentanil and nitroglycerin are safe, efficient and might be advisable for deliberate hypotensive anaesthesia throughout tympanoplasty. However, remifentanil was superior as it provided optimum vision of the surgical site through decreasing intra operative bleeding with reasonable reduction in MAP, and mild tachycardia throughout tympanoplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied deliberate anaesthesia,Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2016
Actual trial start date 01/04/2016
Anticipated date of last follow up 01/04/2017
Actual Last follow-up date 01/04/2017
Anticipated target sample size (number of participants) 27
Actual target sample size (number of participants) 60
Recruitment status Completed
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 nitroglycerin group (group NTG) intravenous nitroglycerin infusion 2¿5 ¿g/kg/min throughout tympanoplasty intravenous nitroglycerin infusion 2¿5 ¿g/kg/min 30
Experimental Group remifentanil group (group REMI) intravenous remifentanil infusion 0.2¿0.5 ¿g/kg/min throughout tympanoplasty intravenous remifentanil infusion 0.2¿0.5 ¿g/kg/min 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 patients of both genders aged 18 to 60 years with an American Society of Anesthesiologists physical status 1 to 2 who were prepared for tympanoplasty under general anesthesia were enrolled Exclusive criteria were; patients aged ¿ 18 years, hypersensitivity to the studied drugs, neuropsychiatric disorders, current opioid or substance abuse, kidney, heart, liver diseases, coagulopathy or drugs affecting coagulation. 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 15/11/2015 Research Ethics Committee, Quality Assurance Unite, Tanta University, faculty of medicine, Approved code: 30633/11/15
Ethics Committee Address
Street address City Postal code Country
Research Ethics Committee, Quality Assurance Unite, Tanta University, faculty of medicine, Approved code: 30633/11/15 tanta 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures were to keep up MAP between 60 and 70 mmHg with ideal vision of operative site The primary outcome measures were to keep up MAP between 60 and 70 mmHg with ideal vision of operative site
Secondary Outcome Surgery time, anesthesia time, deliberate hypotensive anaesthesia times were analyzed. Adverse effects were reported. A four point scale was used for surgeon's satisfaction by the same working surgeon Surgery time, anesthesia time, deliberate hypotensive anaesthesia times were analyzed. Adverse effects were reported. A four point scale was used for surgeon's satisfaction by the same working surgeon
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital tanta cairo 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 tanta cairo 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ashraf alzeftawy tanta cairo 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa elamrousy doaamoha@yahoo.com 00201211865637 algaish street
City Postal code Country Position/Affiliation
tanta 12345 Egypt aasistant professor in tanta university hospital
Role Name Email Phone Street address
Principal Investigator nagat elshmaa nagat_elshmaa@yahoo.com 00101211865637 alstat street
City Postal code Country Position/Affiliation
tanta 12345 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries nagat elshmaa nagat_elshmaa@yahoo.com 00101211865637 alstat street
City Postal code Country Position/Affiliation
tanta 12345 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries momamed elkashlan mohamedkashlan@yahoo.com 00201222364989 alstat street
City Postal code Country Position/Affiliation
tanta 12345 Egypt assistant professor
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information