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.: PACTR201508001247179 Date of Approval: 24/08/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of induced acute arterial hypertension on postoperative nalbuphine analgesic requirement during laparoscopic ovarian cystectomy.
Official scientific title Impact of induced acute arterial hypertension on postoperative nalbuphine analgesic requirement during laparoscopic ovarian cystectomy.
Brief summary describing the background and objectives of the trial 1. Background and Rationale There is a strong relationship between arterial hypertension and decreased sensitivity to painful stimuli was described in animals by Dworkin et al initially and later on in humans by Zamir and Shuber. This association has also been proven in experimental settings with mechanical and pharmacologic models of acute and chronic hypertension. Moreover, in human subjects, not only a decreased sensitivity to pain has been described in the context of chronic hypertension but also the opposite: increased pain sensitivity associated to chronically low blood pressure has been repeatedly demonstrated. Finally , in normotensive subjects, there is an inverse relationship between arterial pressure and pain thresholds. 2. Objectives To evaluate the effectiveness of induced acute hypertension on postoperative nalbuphine analgesic requirements
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Postoperative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 20/11/2015
Actual Last follow-up date 20/11/2015
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hypertension group: the systolic arterial blood pressure will be maintained at 20%-30% above baselin ephdrine increments of 3 mg every 5 minutes 10 min the systolic arterial blood pressure will be maintained at 20%-30% above baseline using ephdrine increments of 3 mg every 5 minutes. The baseline pressure is defined as blood pressure measurement taken in the preoperative setting after 30 minutes of rest in a seated position and before the patient is transported to the operating room. 45
Control Group Control group: the systolic arterial blood pressure will be maintained at 20%-30% below baseline controlled using isoflurane 10 min For patients whose systolic arterial blood pressure will be found to be even lower than the target of 20%-30% below baseline, an ephdrine bolus of 3-5 mg will be used to raise it to target. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 20-50 ASA I-II Elective laparoscopic ovarian cystectomy. Under general anesthesia 90 minutes procedures history of chronic arterial hypertension, a baseline arterial pressure more than 139/89 mm Hg after admission to the hospital, chronic pain, drug abuse, any known cerebrovascular disease, obesity (body mass index > 35), use of any analgesic drugs and/or drugs acting on the central nervous system, known pregnancy, or known adverse effects to the study drugs. 20 Year(s) 50 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 20/08/2015 Anesthesiology department ethical committe
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score 0 1 2 6 12 24 hours
Secondary Outcome hemodynamic, Total dose of analgesics, PONV 0 1 2 4 6 12 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospitals Kasr Al ainy Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University hospital Kasr Al ainy St Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University hospitals, faculty of medicine Kasr Al ainy St Cairo 11562 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Atef Kamel Salama Kasr Al ainy St Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Salama atef.kamel@kasralainy.edu.eg +201001155851 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Public Enquiries NASR MAHMOUD seif.nasr@yahoo.com +201005223734 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Atef Salama atef.kamel@kasralainy.edu.eg +201001155851 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
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