Comparison the effect of Dexmedetomidine and Magnesium Sulphate on hemodynamic changes during laparoscopic cholecystectomy surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017092136312N1

Enrollment

Registered

2017-10-05

Start date

2017-10-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy. Acquired absence of other parts of digestive tract

Interventions

Intervention 1: 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 wit

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

isofolran-N2O and oxygenation with 100% FiO2 as anesthesia maintenance during surgery. Then, intravenous infusion Normal saline intravenous fluid (100 cc during 15 minute). Anesthes

Treatment - Drugs

Placebo

First intervention group: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia

Second intervention group: Intravenous infusion of Midazolam (1 mg/cc) and Fentanyl (100 mcg) as premedication 10 minute before anesthesia

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 Thio

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Systolic and diastolic blood pressure. Timepoint: Before, during, and after surgery. Method of measurement: By sphygmomanometer and in millimeter mercury.;Heart rate. Timepoint: Before, during, and after surgery. Method of measurement: withnon-invasive hemodynamic monitoring device and in beat per minute.;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.	—

Measure

Time frame

Systolic and diastolic blood pressure. Timepoint: Before, during, and after surgery. Method of measurement: By sphygmomanometer and in millimeter mercury.;Heart rate. Timepoint: Before, during, and after surgery. Method of measurement: withnon-invasive hemodynamic monitoring device and in beat per minute.;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

Measure	Time frame
Shivering. Timepoint: after surgery. Method of measurement: observation of patient.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sahar Kamyab

Golestan University of Medical Sciences

Kamyab@goums.ac.ir+98 17 3235 4936

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026