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.: PACTR202105743250047 Date of Approval: 31/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Type of anesthesia and intracranial pressure in laparoscopic surgery
Official scientific title Does the type of anesthesia affect the intracranial pressure in laparoscopic gynecological surgeries ?: A comparative study between propofol and sevoflurane guided by optic nerve sheath diameter measurement.
Brief summary describing the background and objectives of the trial Gynecological surgeries are some of the most frequent surgeries, and laparoscopic techniques have in growing expansion in surgical practice. Trendlenberug position and pneumoperitoneium affect intracranial pressure, which can be detected by optic nerve sheath diameter changes. Anesthestic drugs affect cerebral perfusion and ICP, and hence patients recovery and postoperative symptoms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ICP
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 22/05/2021
Actual trial start date
Anticipated date of last follow up 22/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
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 propofol based anesthesia propofol infusion at a rate 6-10 mg/kg/h intraoperative anaesthesia maintenance based on propofol infusion at a rate 6-10 mg/kg/h., keeping bispectral index 40-60 30
Control Group sevoflurane based anesthesia sevoflurane 1-2% in 40% oxygen air gas mixture. intraoperative anesthesia maintenance based on sevoflurane 1-2% in 40% oxygen air gas mixture, keeping bispectral index 40-6- 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults female ASA I or II aging 18-65 years undergoing laparoscopic gynecological surgeries in mansoura university hospitals. • Patient refusal. • Allergy to used drug. • Altered liver or kidney function. • Brain tumors, swelling, or head trauma. • Diagnosed optic nerve disease (neuritis, trauma, or pathology). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Female
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 06/05/2021 IRB mansoura university egypt
Ethics Committee Address
Street address City Postal code Country
elgomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome optic nerve sheath diameter basal preoperative, post anesthesia induction, post abdominal insufflation, every 30 min till end of surgery, 24 hours postoperative
Secondary Outcome heart rate, mean arterial blood pressure basal preoperative, post anesthesia induction, post abdominal insufflation, every 30 min till end of surgery
Secondary Outcome RASS sedation score 0,1,2,4 hours postoperative
Secondary Outcome bispectral index every 15 min intraoperative till end of surgery
Secondary Outcome posroperative nausea and vomiting 24 hours postoperative
Secondary Outcome recovery time, from end of anesthesia till awake extubation at recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed adel aboelela khattab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university elgomhoria street elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelela aboelela_mohame@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Public Enquiries mohamed aboeelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication, with Researchers who provide a methodologically sound proposal Proposal should be directed to m_abouelela@mans.edu.eg. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (irb_staff@mans.edu.eg)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
irb_staff@mans.edu.eg 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