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.: PACTR202011894723114 Date of Approval: 20/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anesthesia of Sickle Cell Patient in Cameroun
Official scientific title Pharmacodynamic specificities of rocuronium in sickle cell patients
Brief summary describing the background and objectives of the trial Sickle cell disease is the most widespread genetic disease in the world, with the highest prevalence in sub-Saharan Africa. Unlike the general population, sickle cell sufferers are more likely to have surgery in their lifetime. The multiple chronic organ damage due to this disease could lead to variability of responses to the anesthetic drugs. We have undertaken to analyse the pharmacodynamics response of rocuronium to sickle cell patients
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Genetic Diseases,Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/03/2020
Actual trial start date
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
Van Obbergh Luc 2019/0010/HGOPED/DG/CEI
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group curarization monitoring rocuronium: 0.6mg/kg for induction dose and then 0.15mg/kg for any readministration. For the duration of surgery Sickle cell patients and non-sickle cell patients requiring elective laparoscopic surgery: Monitoring of curarisation was done using a TOF scan with a piezoelectric sensor worn between the thumb and index finger, leaving the thumb free to move. The second, third, fourth and fifth fingers were then immobilised so as not to influence thumb movements during the response stimulation. TOF stimulations were given every 15 second on the thumb adductor muscle. The evoked response was displayed on the TOF scan screen. After obtaining a stable response for at least 2 minutes, rocuronium was administered and a stopwatch started. The onset time of action of the neuromuscular blocking agent was considered as the time interval between the end of administration of rocuronium and the appearance of the maximum block (complete disappearance of the four evoked responses to TOF stimulation). The clinical duration of action of neuromuscular blocking agent was the time interval from the end of administration of the neuromuscular blocking agent to the appearance of the first response to TOF stimulation. The reinjection of neuromuscular blocking agent was done after the appearance of the second TOF scan response, and at a dose corresponding to ¼ of the induction dose. The time elapsed before the injection of the 2nd dose of neuromuscular blocking agent and the time taken for the reappearance of the first response (appearance of the first response after the 2nd dose of neuromuscular blocking agent) were noted in all patients. 23 Active-Treatment of Control Group
Experimental Group curarization monitoring rocuronium: 0.6mg/kg for induction dose and then 0.15mg/kg for any readministration. For the duration of surgery Monitoring of curarization was done using a TOF scan with a piezoelectric sensor worn between the thumb and index finger, leaving the thumb free to move. The second, third, fourth and fifth fingers were then immobilised so as not to influence thumb movements during the response stimulation. TOF stimulations were given every 15 second on the thumb adductor muscle. The evoked response was displayed on the TOF scan screen. After obtaining a stable response for at least 2 minutes, rocuronium was administered and a stopwatch started. The onset time of action of the neuromuscular blocking agent was considered as the time interval between the end of administration of rocuronium and the appearance of the maximum block (complete disappearance of the four evoked responses to TOF stimulation). The clinical duration of action of neuromuscular blocking agent was the time interval from the end of administration of the neuromuscular blocking agent to the appearance of the first response to TOF stimulation. The reinjection of neuromuscular blocking agent was done after the appearance of the second TOF scan response, and at a dose corresponding to ¼ of the induction dose. The time elapsed before the injection of the 2nd dose of neuromuscular blocking agent and the time taken for the reappearance of the first response (appearance of the first response after the 2nd dose of neuromuscular blocking agent) were noted in all patients. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sickle cell patients requiring elective laparoscopic surgery (defined as patients who did not require emergency surgery within 12 hours following admission to the hospital), as well as non-sickle cell patients matched to the same types of surgical procedures for the control group were included. After informed consent from patients, we included twenty two “22” patients in the sickle cell patients and twenty three "23" patients in the control group. There were three “03” main indications for surgery: cholecystectomy, appendectomy, and splenectomy. We did not include patients age less than 18 and over 55 years, pregnancy, emergency surgery or surgery within the 12 hours following admission to the ward, predicted difficult ventilation or intubation, body mass index (BMI) over 30, known muscular disease, liver disease and in control group chronic renal disease and ASA 3 patients. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 47 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 21/02/2019 Institutional ethics committee
Ethics Committee Address
Street address City Postal code Country
25 yassa Douala 7270 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The onset time of action of rocuronium was longer in sickle cell patients [mean ± SD (extremes)], [378.22 ± 125.79 (110-600)] than in the control group [150.43 ± 35.62 (83-210)] (P < 0.01). Intubation conditions two “2” minutes after induction doses of rocuronium, as observed from TOF scan data, were not optimal: 20/2 in sickle cell patients and 15/8 in the control group (P = 0,05). The clinical duration of action was shorter in sickle cell patients [19.18 ± 7.12 (13-41)] when compared to the control group [28.96 ± 6.96 min (21-48) min] (P < 0.01). The time before the second dose of rocuronium was given, was shorter in the sickle cell patients group [27.68 ± 7.98 (19-49)] compared to the control group [9.91 ± 8.71 min (30-56 min)] (P < 0.01). The time after which the first response was observed following the second dose of rocuronium was not different in both groups. However, the time to the second response was shorter in the sickle cell patients group [32.64 ± 9.38 (17-53)] compared to the control group [41.48 ± 9.00 min (30-56 min)] (P = 0.002). at the anesthesia induction and during the surgery.
Secondary Outcome The onset time of action of rocuronium was longer in sickle cell patients [mean ± SD (extremes)], [378.22 ± 125.79 (110-600)] than in the control group [150.43 ± 35.62 (83-210)] (P < 0.01). Intubation conditions two “2” minutes after induction doses of rocuronium, as observed from TOF scan data, were not optimal: 20/2 in sickle cell patients and 15/8 in the control group (P = 0,05). The clinical duration of action was shorter in sickle cell patients [19.18 ± 7.12 (13-41)] when compared to the control group [28.96 ± 6.96 min (21-48) min] (P < 0.01). The time before the second dose of rocuronium was given, was shorter in the sickle cell patients group [27.68 ± 7.98 (19-49)] compared to the control group [9.91 ± 8.71 min (30-56 min)] (P < 0.01). The time after which the first response was observed following the second dose of rocuronium was not different in both groups. However, the time to the second response was shorter in the sickle cell patients group [32.64 ± 9.38 (17-53)] compared to the control group [41.48 ± 9.00 min (30-56 min)] (P = 0.002). at the anesthesia induction and during the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gyneaco obstetric and pediatric hospital of Douala. 25 Yassa Douala 7270 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
ARES ULB Av. F. Roosevelt 50 Bruxelles 1050 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ARES ULB Av. F. Roosevelt 50 Brussels 1050 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Basile Essola 10 Logbessou Douala 2701 Cameroon
Aristide Kuitchet Njeunji Jouvance Garoua Cameroon
Raymond Ndikontar Kwinji Ngoussou Yaounde Cameroon
Serges Nga Nomo Essos Yaounde Cameroon
Samantha Benghiat 808 Route de Lennik Brussels 1070 Belgium
Panayota Kapessidou Saint Pierre Brussels Belgium
Michel Baurain 808 Route de Lennik Brussels 1070 Belgium
Luc Van Obbergh 808 Route de Lennik Brussels 1070 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dominique DJOMO TAMCHOM domidjomo@yahoo.fr +237674669260 25 Yassa
City Postal code Country Position/Affiliation
Douala 7270 Cameroon Consultant
Role Name Email Phone Street address
Scientific Enquiries Luc VAN OBBERGH luc.van.obbergh@erasme.ulb.ac.be +32475791757 Route de lennik 808
City Postal code Country Position/Affiliation
Bruxelles 1070 Belgium Professor of Anesthesiology Free University of Brussels
Role Name Email Phone Street address
Public Enquiries Jacob SOUOPGUI jsouopgu@ulb.ac.be +32468080102 Rue des Profs Jeener et Brachet 12
City Postal code Country Position/Affiliation
Gosselies 6041 Belgium Expert for University Cooperation and Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Using a TOF scan, we observed and compared the pharmacodynamic responses of rocuronium after induction dose and reinjection, as well as the intubation conditions in a group of 23 sickle cell patients and a group of 23 controls, all programmed for laparoscopic abdominal surgical procedures. Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication controlled access - cross section data analysis - formal request from the researcher - database administrator - Researchers with minimum of postgraduate qualification.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information