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.: PACTR201611001829308 Date of Approval: 18/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of Dexmedetomidine Or Remifentanyl Continuous Infusion on End-Tidal Sevoflurane Concentration In patients undergoing Laparoscopic Cholecestectomies, Monitored by Bispectral Analysis
Official scientific title The Effects of Dexmedetomidine Or Remifentanyl Continuous Infusion on End-Tidal Sevoflurane Concentration In patients undergoing Laparoscopic Cholecestectomies, Monitored by Bispectral Analysis
Brief summary describing the background and objectives of the trial In this study we evaluated the effects of dexmedetomidine, a selective, short-acting, central ¿ 2-adrenergic agonist or remifentanyl on the sympathetic cardiovascular response and on the expired concentration of sevoflurane during the pnemoperitoneum in order to maintain adequate anesthetic level, by measuring hemodynamic parameters and BIS during laparoscopic cholecystectomies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied laparoscopic cholecystectomies,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2016
Actual trial start date 02/10/2016
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date 01/12/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet 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 randomizarion using a randomization table created by a computer program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo (P group). Group P (n = 40) was the placebo group and received an intravenous (i.v.) saline infusion infusion was stopped 15 min before the end of surgery. All patients had general anesthesia induction, after previous oxygenation for 3 minutes, at anesthesia induction with 1 ¿g.kg-1 of fentanyl , propofol 2.5 mg.kg-1 rocuronium bromide 0.6 mg. kg and sevoflurane 1¿1.5 MAC. Tracheal intubation was performed and patients were mechanically ventilated with 0.95 oxygen inspired fraction (FiO2), 2.5 L.min-1 fresh gas flow and 8 mL.kg-1 tidal volume, with r 40 Placebo
Experimental Group dexmedetomidine (D group) 0.5 ¿g.kg-1.h-1 dexmedetomidine infusions along the surgery stopped 10min before the end of th surgery All patients had general anesthesia induction, after previous oxygenation for 3 minutes, at anesthesia induction with 1 ¿g.kg-1 of fentanyl , propofol 2.5 mg.kg-1 rocuronium bromide 0.6 mg. kg and sevoflurane 1¿1.5 MAC. Tracheal intubation was performed and patients were mechanically ventilated with 0.95 oxygen inspired fraction (FiO2), 2.5 L.min-1 fresh gas flow and 8 mL.kg-1 tidal volume, 40
Experimental Group remifentanil (R group) continuous infusion of 0.2¿0.4 ¿g.kg-1 min along the surgery stopped 10min before the end of th surgery All patients had general anesthesia induction, after previous oxygenation for 3 minutes, at anesthesia induction with 1 ¿g.kg-1 of fentanyl , propofol 2.5 mg.kg-1 rocuronium bromide 0.6 mg. kg and sevoflurane 1¿1.5 MAC. Tracheal intubation was performed and patients were mechanically ventilated with 0.95 oxygen inspired fraction (FiO2), 2.5 L.min-1 fresh gas flow and 8 mL.kg-1 tidal volume, 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II patients scheduled for elective Videolaparoscopic cholecystectomy were included ). Patients were excluded if they had severe cardiac disease, chronic obstructive lung disease, renal and hepatic insufficiency, endocrine, metabolic or central nervous system disorders, a-2-agonist or antagonist therapy taken, and active upper respiratory infection, those receiving medications known to affect MAC, or having a history of alcohol or drug abuse; and women who were lactating or pregnant. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 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 21/10/2016 Tanta Univercity Faculity of Medicine Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
El Bahr St Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome hemodynamic parameters and BIS during laparoscopic cholecystectomies along the surgery
Primary Outcome End-tidal CO2 (ETCO2) concentration and end-expiratory concentration of sevoflurane from the time of anesthesia induction to the time of extubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hospital Elbahr St Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univercity Hospital Elbahr St Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity Hospital Elbahr St Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohamed Mogahed Elmoatasem St Tanta Egypt
Atia Gad Anwar Hassan Radwan Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atteia Gad Anwar atteiagad@gmail.com 04001273693928 Hasan Radwan St
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesiology and ICU
Role Name Email Phone Street address
Public Enquiries Atteia Gad Anwar atteiagad@gmail.com 0201273693928 Hasan Radwan St
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesiology and ICU
Role Name Email Phone Street address
Scientific Enquiries Mona Mogahed monamogahedfr@hotmail.com 00201145130150 El Moatasem St
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesiology and 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