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.: PACTR201608001745312 Date of Approval: 19/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine verus fentanyl as adjuvants to scalp block in patients undergoing elective craniotomy
Official scientific title Dexmedetomidine versus fentanyl as adjuvants to scalp block in patients undergoing elective craniotomy
Brief summary describing the background and objectives of the trial Neural blockade of the scalp has a history that extends over several eras of anesthetic and neurosurgical practice. A ¿¿scalp block¿¿ involves regional anesthesia to the nerves that innervate the scalp, providing analgesia for a considerable period of time with the potential for postoperative e¿ect. Combining regional and general anesthesia has the potential for decreasing intraoperative general anesthetic requirements and attenuating anticipated hemodynamic responses in many patients. Dexmedetomidine (Precedex) is a newly developed selective ¿2-adrenoceptor agonist used as a sedative or adjuvant anaesthetic. It is proved by previes studies that there is a synergistic interactions exist between dexmedetomidine and LA 10 . Fentanyl is a narcotic that has been successfully used as an adjuvant to local anesthetics, prolonging its action with better analgesia and anesthesia 11,12. The aim of this study is to compare the effects of addition of dexmedetomidine and fentanyl to scalp block on hemodynamic stability and postoperative analgesia in patients undergoing craniotomy under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anesthesia and postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2016
Actual trial start date 01/07/2016
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date
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
31059/07/16 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
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 Permuted block randomisation 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
Control Group Group I: Control group ( C ): receive scalp block using 15 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine diluted in normal saline to a total volume of 30 ml. once after induction of GA scalp block 30 Active-Treatment of Control Group
Experimental Group Fentanyl scalp block group ( F ): scalp block using 15 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine and fentanyl 1 ¿g/ml diluted in normal saline to a total volume of 30 ml. once after induction of GA scalp block 30
Experimental Group Dexmedetomidine scalp block group ( D): scalp block using 15 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine and dexmedetomidine 1 ¿g/ml diluted in normal saline to a total volume of 30 ml. once after induction of GA scalp block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 ¿ 60 years either gender ASA I-III undergoing elective supratentorial craniotomy includes patient refusal inability to understand and incapacity to use VAS score allergy to studied drugs significant pathology at the sites of infiltration patients who were chosen for elective postoperative ventilation and post-inclusion postoperative ventilation. 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 01/07/2016 Tanta University, Faculty of Medicine, research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS 0 ( immediately after transport to PACU), 1, 2 , 4 , 6 , 12, and 24 h.
Primary Outcome ¿ Duration of analgesia time from block administration till first analgesic request .
Secondary Outcome ¿ HR and MAP before induction, 5 min after intubation, at time of incision, every 5 minutes for ¿rst 15 minutes, and then every half an hour till 2hours of the intraoperative period. after extubation at same times of VAS score.
Secondary Outcome ¿ Time of first analgesic request. when occurs
Secondary Outcome ¿ Total intraoperative fentanyl consumption. immediate postoperative
Secondary Outcome Total consumption of rescue analgesia 24 h postoperative
Secondary Outcome Postoperative sedation if occured
Secondary Outcome complications if occured
Secondary Outcome patient satisfaction 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine. Tanta University Tanta Geish Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Anesthesia and Surgical ICU, Tanta University Tanta, Geish street Tanta Egypt Hospital
Primary Sponsor Tanta University Tanta Geish Street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohamed Shebl Abdelghany 9 Abdelgleel Altawab Tanta Egypt
Gehan Morsy Eid 7 Tharwat Street, Hassan Radwan Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Shebl moh7000@yahoo.com 01063345623 9 Abdelgleel Altawab
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
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