(1) Objective: Comparison the effect of Dexmedetomidine and Magnesium Sulphate on hemodynamic changes during laparoscopic cholecystectomy surgery
(2) Design: Double blind randomized controlled trial
(3) Setting and conduct: Selecting 90 patients undergoing cholecystectomy surgery in 5 Azar tertiary hospital affiliated to Golestan university of medical sciences and assigning them to three groups by simple random allocation method.
(4) Participants including major eligibility criteria: age between 18 to 55 years; American Society of Anesthesiologists (ASA) physical status classification system I and II; under general anesthesia and tracheal intubation; filling the written informed consent form. Exclusion Criteria: with cardiovascular, hepatic, and renal diseases; substance abuse; Body Mass Index (BMI) greater than 30; Mallampati classification class III and IV.
(5) Intervention: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia for three groups; isofolran-N2O and oxygenation with 100% FiO2 as anesthesia maintenance during surgery for 3 group. Then, intravenous infusion of Dexmedetomidine (0.5 mg/kg in 100 cc normal saline during 15 minute) for first group, Magnesium Sulphate (2 gr in 100 cc normal saline intravenous fluid during 15 minute) for second group; and Normal saline intravenous fluid (100 cc during 15 minute) for third group. Anesthesia with Sodium Thiopental (5 mg/ kg), and Atracurium (0.2 mg/ kg) and Fentanyl (1 mg/ kg) and tracheal intubation for 3 groups. Then, intravenous infusion of maintenance dosage of Dexmedetomidine (0.4 mg/kg/hr) for first group, Magnesium Sulphate (15 mg/ kg/ hr) for second group; and Normal saline intravenous fluid for third group. At the end of the surgery, discontinuation of intravenous infusions and isofolran-N2O and intravenous injection of Atropine (0.02 mg/kg) and Neostigmine (0.5 mg/ kg) and tracheal extubation and transferring patients with Modified Aldret Score ≥ 9 from recovery to surgery unit.
(6) Main outcome measures (variable): Systolic and diastolic blood pressure; mean arterial pressure (MAP); Heart rate (HR); and shivering after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092136312N1
Registration date:2017-10-05, 1396/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Sahar Kamyab
Name of organization / entity
Golestan university of Medical Sciences, Gorgan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 4936
Email address
kamyab@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences, Gorgan, Iran
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Dexmedetomidine and Magnesium Sulphate on hemodynamic changes during laparoscopic cholecystectomy surgery
Public title
Comparison the effect of Dexmedetomidine and Magnesium Sulphate on hemodynamic changes during laparoscopic cholecystectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Participants including major eligibility criteria: age between 18 to 55 years old; American Society of Anesthesiologists (ASA) physical status classification system I and II; under general anesthesia and tracheal intubation; filling the written informed consent form. Exclusion Criteria: with cardiovascular, hepatic, and renal diseases; substance abuse; Body Mass Index (BMI) greater than 30; Mallampati classification class III and IV.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Shastkola Road, Educational Campus of Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Postal code
4934174515
Approval date
2017-08-13, 1396/05/22
Ethics committee reference number
IR.GOUMS.REC.1396.128
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
Before, during, and after surgery
Method of measurement
By sphygmomanometer and in millimeter mercury
2
Description
Heart rate
Timepoint
Before, during, and after surgery
Method of measurement
withnon-invasive hemodynamic monitoring device and in beat per minute
3
Description
Mean Arterial Pressure (MAP)
Timepoint
Before, during, and after surgery
Method of measurement
derived from Systolic Blood Pressure and Diastolic Blood Pressure and in millimeter mercury
Secondary outcomes
1
Description
Shivering
Timepoint
after surgery
Method of measurement
observation of patient
Intervention groups
1
Description
First intervention group: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia; isofolran-N2O and oxygenation with 100% FiO2 as anesthesia maintenance during surgery.Then, intravenous infusion of Dexmedetomidine (0.5 mg/kg in 100 cc normal saline during 15 minute). Anesthesia with Sodium Thiopental (5 mg/ kg), and Atracurium (0.2 mg/ kg) and Fentanyl (1 mg/ kg) and tracheal intubation. Then, intravenous infusion of maintenance dosage of Dexmedetomidine (0.4 mg/kg/hr). At the end of the surgery, discontinuation of intravenous infusions and isofolran-N2O and intravenous injection of Atropine (0.02 mg/kg) and Neostigmine (0.5 mg/ kg) and tracheal extubation and transferring patients with Modified Aldret Score ≥ 9 from recovery to surgery unit.
Category
Treatment - Drugs
2
Description
Second intervention group: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia; isofolran-N2O and oxygenation with 100% FiO2 as anesthesia maintenance during surgery. Then, intravenous infusion of Magnesium Sulphate (2 gr in 100 cc normal saline intravenous fluid during 15 minute). Anesthesia with Sodium Thiopental (5 mg/ kg), and Atracurium (0.2 mg/ kg) and Fentanyl (1 mg/ kg) and tracheal intubation. Then, intravenous infusion of maintenance dosage of Magnesium Sulphate (15 mg/ kg/ hr). At the end of the surgery, discontinuation of intravenous infusions and isofolran-N2O and intravenous injection of Atropine (0.02 mg/kg) and Neostigmine (0.5 mg/ kg) and tracheal extubation and transferring patients with Modified Aldret Score ≥ 9 from recovery to surgery unit.
Category
Treatment - Drugs
3
Description
Placebo group: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia; isofolran-N2O and oxygenation with 100% FiO2 as anesthesia maintenance during surgery. Then, intravenous infusion Normal saline intravenous fluid (100 cc during 15 minute). Anesthesia with Sodium Thiopental (5 mg/ kg), and Atracurium (0.2 mg/ kg) and Fentanyl (1 mg/ kg) and tracheal intubation. Then, intravenous infusion of Normal saline intravenous fluid. At the end of the surgery, discontinuation of intravenous infusions and isofolran-N2O and intravenous injection of Atropine (0.02 mg/kg) and Neostigmine (0.5 mg/ kg) and tracheal extubation and transferring patients with Modified Aldret Score ≥ 9 from recovery to surgery unit.