Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this double-blind randomized study will be to evaluate the effect an intravenous infusion of magnesium has on recovery outcomes after elective laparoscopic cholecystectomy
Magnesium consists one of the most important electrolytes of the human body, producing effects in various systems, one of them being the central nervous system. It has been shown that the administration of intravenous magnesium sulphate during anesthesia can significantly reduce the requirements for anaesthetic and analgesic agents, perioperatively, and improve the quality of post anesthetic recovery. The present study will examine the effect of administering intravenous magnesium sulphate during anesthesia in patients undergoing elective laparoscopic cholecystectomy surgery. This is a single centre, double-blinded, randomised controlled trial in an adult population, taking place in a tertiary medical centre in Athens. The study consists of three comparison groups of equivalent population, produced by double blinded randomisation. Each comparison arm will be administered a different regimen of magnesium sulphate/placebo. During the perioperative time, depth of anaesthesia will be monitored using the Bispectral Index, (BIS™) and the nociceptive level with nociception level index (NOL®). Dosing of the anaesthetic agent, desflurane, as well as of the analgesic medication, remifentanil, will be adjusted according to the prior indices. Patients included in the study will be monitored in the PACU and the surgical ward for the first 24 hours, postoperatively. Primary outcomes include the requirements for anaesthetic and analgesic agents, time to emergence, time to extubation, time to recovery, quality of recovery variables, pain scores during the first 24 hours and adverse effects and/or complications of magnesium administration. Ethical approval for this trial has been granted by the Ethics Committee of the hospital.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium bolus | Active Comparator | A bolus dose of magnesium of 40 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, normal saline will be administered at a rate of 20 mL/h |
|
| magnesium bolus and magnesium infusion | Active Comparator | A bolus dose of magnesium of 40 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 10 mg/kg/h of magnesium will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h |
|
| placebo | Placebo Comparator | 100 mL of normal saline will be administered within 10 minutes preoperatively. Followingly, normal saline will be administered at a rate of 20 mL/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium bolus followed by normal saline infusion | Drug | a bolus dose of magnesium will be followed by normal saline infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score on arrival to Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | immediately postoperatively |
| pain score at discharge from Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively |
| pain score 24 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 24 hours postoperatively |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| time to first request for analgesia | the time for the first patient request for analgesia will be noted | during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively |
| morphine consumption in Post-Anesthesia Care Unit (PACU) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KASSIANI THEODORAKI, PhD, DESA | Contact | +306974634162 | ktheodoraki@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| KASSIANI THEODORAKI, PhD, DESA | Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Nikea | Recruiting | Piraeus | Attiki, Greece | 18454 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28214095 | Background | Haryalchi K, Abedinzade M, Khanaki K, Mansour Ghanaie M, Mohammad Zadeh F. Whether preventive low dose magnesium sulphate infusion has an influence on postoperative pain perception and the level of serum beta-endorphin throughout the total abdominal hysterectomy. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):384-390. doi: 10.1016/j.redar.2016.11.009. Epub 2017 Feb 14. English, Spanish. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| magnesium bolus followed by magnesium infusion | Drug | a bolus dose of magnesium will be followed by a magnesium infusion |
|
| normal saline bolus followed by normal saline infusion | Drug | a bolus of normal saline will be followed by normal saline infusion |
|
mg of morphine requested during patient PACU stay
| immediately postoperatively |
| pethidine consumption in the first 48 hours | patients will be followed for cumulative pethidine consumption for 48 hours postoperatively | 48 hours postoperatively |
| remifentanil requirement during surgery | dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value | intraoperatively |
| number of participants experiencing side effects intraoperatively | patients will be monitored for side-effects of the administered agents intraoperatively | intraoperatively |
| number of participants experiencing side effects postoperatively | patients will be monitored for side-effects of the administered agents postoperatively | 48 hours postoperatively |
| time to emergence | time from desflurane discontinuation to first patient response (eye opening) | end of operation, approximately 1 hour after start of surgery |
| time to extubation | time from desflurane discontinuation to tracheal extubation | end of operation, approximately 1 hour after start of surgery |
| duration of nociception level<25 intraoperatively | nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia | intraoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D059226 | Nociceptive Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided