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.: PACTR201811703495809 Date of Approval: 14/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of calcium chloride on recovery from neuromuscular block
Official scientific title Efficacy of calcium chloride supplementary to neostigmine on recovery from neuromuscular blockade. A randomized controlled study.
Brief summary describing the background and objectives of the trial Skeletal muscle relaxants are used to facilitate endotracheal intubation and provide paralysis required for different surgeries performed under general anesthesia. Postoperative residual block (RNMB), defined as TOF ratio <0.9 1 is present in 63.5% of patients at tracheal extubation and in 56.5% on arrival at the PACU 2. It remains a major problem that adversely impacts the patient's clinical outcome due to different complications as hypoxia, pulmonary aspiration of gastric content, weakness, atelectasis, and pneumonia3. Ionized calcium has an unpredictable effect at the neuromuscular junction. Although it increases the release of acetylcholine from the motor nerve ending facilitating the excitation-contraction coupling7, it may decrease the degree of depolarization at the motor end plate8. Ju JW and his colleagues studied the effects of administering calcium chloride (5mg/kg) supplementary to neostigmine on recovery from the neuromuscular blockade and concluded that it enhanced the early recovery of non-depolarising neuromuscular blockade without significant improvement in clinical outcomes.9 So, the investigators hypothesized that increasing the calcium chloride dose (10mg/kg) would exert more enhancement on the rate of neuromuscular recovery that might shorten the time to extubation and reduce the incidence of RNMB after surgery. The aim of this study is to evaluate the effect of administering calcium chloride (10mg/kg) with neostigmine at the end of anesthesia on neuromuscular recovery and extubation time
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/11/2018
Actual trial start date
Anticipated date of last follow up 01/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group neostigmine group. normal saline will be injected ( same volume as that of the CaCl used in the other group). With the return of the fourth twitch of TOF (TOFC-4), at three consecutive TOF measurements General anesthesia will be induced. At the end of surgery, spontaneous recovery from the NMB will be allowed. With the return of the fourth twitch of TOF (TOFC-4), at three consecutive TOF measurements, patients will receive neostigmine 50 µg/kg mixed with atropine 20 µg/kg and normal saline will be injected. 33 Placebo
Experimental Group Calcium chloride group. 10mg/kg calcium chloride. With the return of the fourth twitch of TOF (TOFC-4), at three consecutive TOF measurements. General anesthesia will be induced. At the end of surgery, spontaneous recovery from the NMB will be allowed. With the return of the fourth twitch of TOF (TOFC-4), at three consecutive TOF measurements, patients will receive neostigmine 50 µg/kg mixed with atropine 20 µg/kg plus 10mg/kg calcium chloride will be injected. 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients of either sex. 18 to 65 years old. ASA physical status I–III. scheduled for elective surgery under general anesthesia with intubation of the trachea, of an expected duration of ≥ 60 min Patients with the suspected difficult airway. Chronic obstructive pulmonary disease or bronchial asthma. BMI ≥ 40. Neuromuscular diseases. Suspected malignant hyperthermia. Glaucoma. renal or hepatic dysfunction. Taking medications that could affect NMB agents action. Pregnant or lactating women. Patients with hypo or hypercalcemia. Hypo-albuminemia. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 19/05/2018 Institutional Review Board Mansoura Faculty of Medicine.
Ethics Committee Address
Street address City Postal code Country
Al Gomhoria Street Mansoura 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Extubation time at the time of extubation
Secondary Outcome 1. Recovery time (time from administration of neostigmine till reaching TOF ratio ≥ 0.9). 2. Core body temperature, sevoflurane concentration, serum ionized calcium level, and arterial blood PH at the time of neostigmine administration. 3. Total atracurium dose used during the surgery. 4. TOFr at 5,10,20,30 min after neostigmine administration and at PACU arrival. 5. Time from neostigmine administration to PACU arrival. 6. The incidence of a residual neuromuscular block (TOFr less than 0.9 on quantitative monitoring) 13, measured at the same intervals as TOFr. 7. PACU discharge time (time from PACU admission till reaching modified Aldrete's score of ≥ 9). As mentioned above
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals. Al Gomhoria street Mansoura 123456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded al Gomhoria street Mansoura 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Hospitals. Al Gomhoria street Mansoura 12345 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Eslam Elshehawi Al gomhoria street Mansoura 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samah El Kenany sk_20022000@yahoo.com 00201002262557 Hay El Gamaa street
City Postal code Country Position/Affiliation
Mansoura 12345 Egypt MD Lecturer of anesthesia surgical intensive care and pain management.
Role Name Email Phone Street address
Scientific Enquiries Mohamed Eslam El Shehawi melshehawi@gmail.com 00201000035990 Al Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 12345 Egypt MD Lecturer of anesthesia surgical intensive care and pain management
Role Name Email Phone Street address
Public Enquiries Samah El Kenany Sk_20022000@yahoo.com 00201002262557 Hay Al Gamaa
City Postal code Country Position/Affiliation
Mansoura 12345 Egypt MD Lecturer of anesthesia surgical intensive care and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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 URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information