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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000508572
Date of registration: 20/05/2015
Prospective Registration: No
Primary sponsor: mansura university hospital
Public title: The effect of adding magnesium sulphate to fentanyl and bupivacaine for spinal anaesthesia in patients undergoing lower limb orthopedic surgery
Scientific title: The effect of adding magnesium sulphate to fentanyl and bupivacaine on the duration of spinal anaesthesia in patients undergoing lower limb orthopedic surgery
Date of first enrolment: 01/03/2015
Target sample size: 99
Recruitment status: Recruiting
URL:  https://anzctr.org.au/ACTRN12615000508572.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial;  
Phase: 
Countries of recruitment
Egypt
Contacts
Name: Dr Mohamed Gad El Dosoky   
Address:  mansura university, faculty of medicine ,Egypt . egypt,mansura,Dakahlia Governorate gihan sreet Egypt
Telephone: +20 1093019320
Email: dr_mohamedgad2000@yahoo.com
Affiliation: 
Name: Dr Mohamed Gad El Dosoky   
Address:  mansura university, faculty of medicine ,Egypt . egypt,mansura,Dakahlia Governorate gihan sreet Egypt
Telephone: +20 1093019320
Email: dr_mohamedgad2000@yahoo.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. ASA statuses I or II patients.
2. Aged between 20 and 60 years old.
3. Patients scheduled for elective lower limb surgery.
4. Both sexes.

Exclusion criteria: 1. Patient refusal.
2. Hepatic or renal impairment.
3. Neuromuscular diseases.
4. History of opioid abuse.
5. History of allergy to anesthetic drugs.
6. Infection at the lumbar area.
7. Coagulopathies.
8. Increased intra cranial tension (ICP).
9. Cardiovascular & respiratory diseases.


Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
duration of spinal anaesthesia in lower limb orthopedic surgery;
duration of spinal anaesthesia in lower limb orthopedic surgery
Anaesthesiology - Anaesthetics
Intervention(s)
Patients will be randomly allocated to one of three groups (33 patients in each group) using closed envelop method.
Group F (n=33): patients will receive a premixed solution of 3 ml (0.5%) hyperbaric bupivacaine, 0.5 mL (25 microgram fentanyl) with 0.5 ml preservative free saline by spinal injection.
Group M(n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mLof 10% MgSO4 with 0.5 ml preservative free saline by spinal injection.
Group M + F (n=33): patient will receive a premixed solution of 3ml (0.5%) of hyperbaric bupivacaine, 0.5 mL (25 microgram) fentanyl with 0.5 mL of 10% MgSO4 by spinal injection.
Lumbar puncture for the patients in the sitting position will be performed under complete aseptic conditions at L3-4 or L4-5 interspaces with a 25- gauge spinal needle using a midline approach. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, the premixed anesthetic solution will be injected. Immediately after intrathecal injection of the local anaesthetic, patients will be turned into the supine position. Oxygen 3 L/min was applied to all patients via nasal prongs. Surgery will be permitted after ensuring T8 sensory block to pin-prick.
Primary Outcome(s)
duration of spinal anesthesia[ Duration of spinal anesthesia will be assessed as the period from spinal injection to the time of administration of first rescue analgesic for pain postoperatively. ]
Secondary Outcome(s)
onset and duration of motor block.[Motor blockade of the lower extremity muscles will be assessed using Bromage Score: (0= no motor block, ability to raise hips, knees,and ankles. 1 = unable to raise extended legs, able to move knees and feet. 2= unable to raise extended leg or move knee; able to move feet.3= unable to move any part of the lower limbs), measurements included the onset (time from induction of spinal anesthesia till Bromage = 3) and duration (time from complete block till Bromage =0).motor block will be assessed every 2min, 4min , 6min ,8min , 10min , 20min , 40min , 60min , 80min , 100min , 120min 140min , 160min , 180min and 200mins .]
The incidence of side effects.[Nausea, vomiting,bradycardia, low blood pressure, shivering, sedation, and itching and urine retention will be reported every 1 hour up to 24 hours post oprative. Return of bladder function (passing urine) or bowel movements (passing flatus/stools) in first 24 hours will be recorded as present/ absent and the time of their return will be also recorded.]
The time and amount of post-operative analgesic requirement[At the end of surgery, patients will be transferred to the PACU. The level of pain based on visual analog scale (VAS) (where 0= no pain and 100= worst pain) will be assessed immediately after surgery, 1 h, 2 h, 4h, 6 h, 8h, 12h, 16h, 20h and 24 h after surgery.Whenever VAS >30, postoperative analgesia will be provided with i.v. ketorolac 30 mg/6 h. After 30 min of ketorolac injection, i.v. fentanyl 0.5 micro gram/kg will be available if VAS still >30. Fentanyl injection can be repeated, provided that 4 h at least should be passed since the last dose]
onset and time of sensory block .[ sensory block will be assessed by pin-prick exam , time to sensory block (time from intrathecal injection of drugs to reach T10 sensory level), the highest dermatomal level , the time to two segments regression from the previous highest dermatomal level, and the duration of sensory block (time from the onset of sensory block till regression to S1).
Sensory block will be evaluated at the same time interval as the hemodynamic variables every 2min, 4min , 6min ,8min , 10min , 20min , 40min , 60min , 80min , 100min , 120min 140min , 160min , 180min and 200mins .]
Secondary ID(s)
nil
Source(s) of Monetary Support
mansura university hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
the Medical Research Ethics Committee, Faculty of medicine, Mansura University.
Results
Results available:
Date Posted:
Date Completed:
URL:
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