Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160598
Status:
UNKNOWN
Last Update Posted:
2020-09-04
First Post:
2019-11-09
Brief Title:
Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence A Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Adding opioids to local anesthetic solutions leads to enhanced anesthesia and provide postoperative analgesia Intrathecaly injected opioids have some side effects though One of them is pruritus Objective We designed a randomized double-blinded placebo-controlled study to evaluate prophylactic impact of continuous IV Magnesium 10mgkg over 30 minutes on intrathecal fentanyl-induced pruritus start at the end of the operation
Methods ASA I-II Patients candidate for orthopedic operations under spinal anesthesia 10-15mg hyperbaric bupivacaine and 25 µg fentanyl intrathecal and will be divided randomly into two groups
Control group Placebo group bolus 100 ml nacl 09 at end of surgery Study group Mg group continuous IV Magnesium 10mgkg in 100 ml Nacl09 over 30 minutes at end of surgery
Study outcome
1 Hemodynamics Systolic blood pressure Mean arterial blood pressure pulse rate O2 saturation will be recorded in 5 min10 min30 min60 min and every one hour till 6 hours after the operation
2 Pruritus Patients were asked about existence present1no0 severity mild1 modret2 sever 3 and site of pruritus Facetrigeminal 1 neuroaxialdermatome2 124 and 6 hours after operation Incidence of pruritus total group incidence
3 The incidence of PONV
Methods ASA I-II Patients candidate for orthopedic operations under spinal anesthesia 10-15mg hyperbaric bupivacaine and 25 µg fentanyl intrathecal and will be divided randomly into two groups
Control group Placebo group bolus 100 ml nacl 09 at end of surgery Study group Mg group continuous IV Magnesium 10mgkg in 100 ml Nacl09 over 30 minutes at end of surgery
Study outcome
1 Hemodynamics Systolic blood pressure Mean arterial blood pressure pulse rate O2 saturation will be recorded in 5 min10 min30 min60 min and every one hour till 6 hours after the operation
2 Pruritus Patients were asked about existence present1no0 severity mild1 modret2 sever 3 and site of pruritus Facetrigeminal 1 neuroaxialdermatome2 124 and 6 hours after operation Incidence of pruritus total group incidence
3 The incidence of PONV
Detailed Description:
Study hypothesis Intravenous Magnesium would reduce and improve post-spinal fentanyl pruritus incidence outcome relaying up on the fact that Magnesium ions block the neuroaxial NMDA receptor which are involved in histamine-induced expansion of mechanical receptive field area a neural event possibly involved in the development of pruritis 36 Aim of the work To introduce Magnesium sulphate as cheap effective alternative for prevention and management of post-spinal opioid pruritis
Methods This prospective randomized double blinded controlled study will be carried out in Mansoura faculty of medicine in Mansoura University hospital on cases subjected to LL orthopedic operations under spinal anesthesia utilizing bupivacaine plus adjuvant fentanyl which is documented to have high incidence of postspinal pruritus
Patients ASA I-II of both genders aged 20-70 years old Patients candidate for LL orthopedic operations under spinal anesthesia Total patient number of 144 will be enrolled into two groups 72 patients each all patients will be anesthetized intrathecaly using10-15mg hyperbaric bupivacaine and 30 µg fentanyl and will be subdivided randomly into two groups
Control group Placebo Group bolus 50 ml Nacl 09 at the end of surgery over 20 minutes 5mlminute infusion rate
Study group MG Group continuous IV infusion pump of Magnesium 10mgkg in 50 ml Nacl09 over 20 minutes at end of surgery 5mlminute infusion rate
Randomization and blindness the study drugs were prepared in 50 ml saline syringe according to the study randomization envelop method by an anesthesiologist who did not participate in the care and evaluation of the patients The investigator and the patients were not aware of the drug they received
Study outcomes were assessed by the same clinician who cared for the patients in the perioperative and postoperative periods
1 Demographic data Age weight length BMI operative type and operative time
2 Hemodynamics
Systolic blood pressure mean arterial blood pressure heart rate O2 saturation will be recorded basal 10 min 30 min 60 min and every one hour till 6 hours after operation then every 6 h for the 1st 12 h after surgery
3 Pruritus Primary outcome Incidence of pruritus in each group incidence Includes 3 items 1 Existence present1 no0 2 Severity mild1 modret2 sever 3 3 Site of pruritus Face trigeminal 1 neuraxial dermatome 2 during the 1st 6 hours after spinal fentanyl injection
4 PO 1st 24 h Magnesium dose
5 PO 1st 24 h Naloxone
6 The incidence of PO vomiting in each group -Exclusion Criteria BMI35 Patient refusal Hypersensitivity to amide local anesthetics Fentanyl opioids Magnesium and naloxone Patients with coagulopathy hepatic failure LBBB and trifacicular block General contraindications to spinal anesthesia surgeon total refusal Cardiac hepatic renal or respiratory failure Difficult communication with the patient psychological or deafness
Side effects Management
1 Residual Sever pruritus after the 1st magnesium bolus will be controlled 1st by 2 second postoperative 10mgkg dose of magnesium bolus IV if not controlled within one hour Naloxone bolus dose of 04 mg then if pruritus attack not controlled another 04 mg naloxone in 100ml normal saline iv infusion over the next 1hour during the postoperative 12 hours
2 Moderate Abdominal Pain VAS 4 during surgical manipulation is unaccepted and managed soon using multimodal analgesia regimen including ketorolac slow injection in an IV bolus of 05mgkg if general anesthesia needed to control pain case will be excluded from the study
3 Nausea Vomiting treated by metoclopramide 10 mg if resistant IV bolus ondansetron 4mg with treatment of hypotension if present
4 Hypotension mean arterial blood pressure MAP less than 65 mmHg will be managed by using ephedrine bolus doses of 6mg fluids and blood transfusion according to events and requirements
5 Bradycardia HR less than 60 bm will be managed by atropine bolus of 05 mg
6 Desaturation SaO2 90 will be managed by increase oxygen face mask flow up to 10 Lsec and dealing with the airway according to the situation targeting a patient airway with breathing comfort and O2saturation94 In case of any respiratory depression emergency airway equipments and drugs for resuscitation for airway management and ventilation were kept ready
Sample size calculation Sample size was calculated using Power Analysis and Sample Size software program PASS version 1505 for windows 2017 using the results published by SS Jahanbakhsh and S Bazyar Study on prophylactic impact of ondansetron IV on intrathecal fentanyl-induced pruritus British Journal of Anesthesia 108 S2 ii387-ii437 2012 doi101093bjaaer489 37 With the incidence of post-operative opioid induced pruritis after spinal anesthesia as the primary outcome Patients will be allocated into two groups control group placebo Group and the study group MG Group Jahanbakhsh 2012 resulted in post-spinal fentanyl induced pruritus incidence of 34 ondansetron group versus 60 in the placebo group The null hypothesis is assumed to be the absence of difference between both treatment modalities A sample of 65 patients is in each group needed to achieve 80 power 1-β or the probability of rejecting the null hypothesis when it is false to detect a difference between the group proportions of 26 using two-sided Fishers exact test with a significance level of 005α or the probability of rejecting the null hypothesis when it is true The expected number of dropouts is 7 patients in each group so 72 patients will be enrolled into each group with a total study sample size number of 144 patients
Statistical analysis IBMs SPSS Statistics Statistical Package for the Social Sciences for Windows version 25 will be used for statistical analysis of the collected data Shapiro-Wilk test will be used to check the normality of the data distribution Normally distributed continuous variables will be expressed as mean SD while categorical variables and the abnormally distributed continuous ones will be expressed as median and inter-quartile range or number and percentage as appropriate Student t-test and Mann-Whitney will be used for normally and abnormally distributed continuous data respectively Chi-square tests will be used for categorical data using the crosstabs function All tests will be conducted with a 95 confidence interval If needed bivariate correlations will be assessed using Pearsons or Spearmans correlation coefficient depending on the nature of data P probability value 005 will be considered statistically significant
Methods This prospective randomized double blinded controlled study will be carried out in Mansoura faculty of medicine in Mansoura University hospital on cases subjected to LL orthopedic operations under spinal anesthesia utilizing bupivacaine plus adjuvant fentanyl which is documented to have high incidence of postspinal pruritus
Patients ASA I-II of both genders aged 20-70 years old Patients candidate for LL orthopedic operations under spinal anesthesia Total patient number of 144 will be enrolled into two groups 72 patients each all patients will be anesthetized intrathecaly using10-15mg hyperbaric bupivacaine and 30 µg fentanyl and will be subdivided randomly into two groups
Control group Placebo Group bolus 50 ml Nacl 09 at the end of surgery over 20 minutes 5mlminute infusion rate
Study group MG Group continuous IV infusion pump of Magnesium 10mgkg in 50 ml Nacl09 over 20 minutes at end of surgery 5mlminute infusion rate
Randomization and blindness the study drugs were prepared in 50 ml saline syringe according to the study randomization envelop method by an anesthesiologist who did not participate in the care and evaluation of the patients The investigator and the patients were not aware of the drug they received
Study outcomes were assessed by the same clinician who cared for the patients in the perioperative and postoperative periods
1 Demographic data Age weight length BMI operative type and operative time
2 Hemodynamics
Systolic blood pressure mean arterial blood pressure heart rate O2 saturation will be recorded basal 10 min 30 min 60 min and every one hour till 6 hours after operation then every 6 h for the 1st 12 h after surgery
3 Pruritus Primary outcome Incidence of pruritus in each group incidence Includes 3 items 1 Existence present1 no0 2 Severity mild1 modret2 sever 3 3 Site of pruritus Face trigeminal 1 neuraxial dermatome 2 during the 1st 6 hours after spinal fentanyl injection
4 PO 1st 24 h Magnesium dose
5 PO 1st 24 h Naloxone
6 The incidence of PO vomiting in each group -Exclusion Criteria BMI35 Patient refusal Hypersensitivity to amide local anesthetics Fentanyl opioids Magnesium and naloxone Patients with coagulopathy hepatic failure LBBB and trifacicular block General contraindications to spinal anesthesia surgeon total refusal Cardiac hepatic renal or respiratory failure Difficult communication with the patient psychological or deafness
Side effects Management
1 Residual Sever pruritus after the 1st magnesium bolus will be controlled 1st by 2 second postoperative 10mgkg dose of magnesium bolus IV if not controlled within one hour Naloxone bolus dose of 04 mg then if pruritus attack not controlled another 04 mg naloxone in 100ml normal saline iv infusion over the next 1hour during the postoperative 12 hours
2 Moderate Abdominal Pain VAS 4 during surgical manipulation is unaccepted and managed soon using multimodal analgesia regimen including ketorolac slow injection in an IV bolus of 05mgkg if general anesthesia needed to control pain case will be excluded from the study
3 Nausea Vomiting treated by metoclopramide 10 mg if resistant IV bolus ondansetron 4mg with treatment of hypotension if present
4 Hypotension mean arterial blood pressure MAP less than 65 mmHg will be managed by using ephedrine bolus doses of 6mg fluids and blood transfusion according to events and requirements
5 Bradycardia HR less than 60 bm will be managed by atropine bolus of 05 mg
6 Desaturation SaO2 90 will be managed by increase oxygen face mask flow up to 10 Lsec and dealing with the airway according to the situation targeting a patient airway with breathing comfort and O2saturation94 In case of any respiratory depression emergency airway equipments and drugs for resuscitation for airway management and ventilation were kept ready
Sample size calculation Sample size was calculated using Power Analysis and Sample Size software program PASS version 1505 for windows 2017 using the results published by SS Jahanbakhsh and S Bazyar Study on prophylactic impact of ondansetron IV on intrathecal fentanyl-induced pruritus British Journal of Anesthesia 108 S2 ii387-ii437 2012 doi101093bjaaer489 37 With the incidence of post-operative opioid induced pruritis after spinal anesthesia as the primary outcome Patients will be allocated into two groups control group placebo Group and the study group MG Group Jahanbakhsh 2012 resulted in post-spinal fentanyl induced pruritus incidence of 34 ondansetron group versus 60 in the placebo group The null hypothesis is assumed to be the absence of difference between both treatment modalities A sample of 65 patients is in each group needed to achieve 80 power 1-β or the probability of rejecting the null hypothesis when it is false to detect a difference between the group proportions of 26 using two-sided Fishers exact test with a significance level of 005α or the probability of rejecting the null hypothesis when it is true The expected number of dropouts is 7 patients in each group so 72 patients will be enrolled into each group with a total study sample size number of 144 patients
Statistical analysis IBMs SPSS Statistics Statistical Package for the Social Sciences for Windows version 25 will be used for statistical analysis of the collected data Shapiro-Wilk test will be used to check the normality of the data distribution Normally distributed continuous variables will be expressed as mean SD while categorical variables and the abnormally distributed continuous ones will be expressed as median and inter-quartile range or number and percentage as appropriate Student t-test and Mann-Whitney will be used for normally and abnormally distributed continuous data respectively Chi-square tests will be used for categorical data using the crosstabs function All tests will be conducted with a 95 confidence interval If needed bivariate correlations will be assessed using Pearsons or Spearmans correlation coefficient depending on the nature of data P probability value 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None