Analgesia, Magnesium, Pain, Acute, Pain, Nociceptive, Pain, Postoperative
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGmagnesium bolus followed by normal saline infusion
a bolus dose of magnesium will be followed by normal saline infusion
DRUGmagnesium bolus followed by magnesium infusion
a bolus dose of magnesium will be followed by a magnesium infusion
DRUGnormal saline bolus followed by normal saline infusion
a bolus of normal saline will be followed by normal saline infusion
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patents * American Society of Anesthesiologists (ASA) class I-III * elective laparoscopic cholecystectomy
Exclusion criteria
* body mass index (BMI) \>35 kg/m2 * systematic use of analgesic agents preoperatively * chronic pain syndromes preoperatively * neurological or psychiatric disease on treatment * pregnancy * severe hepatic or renal disease * drug or alcohol abuse * language or communication barriers lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score on arrival to Post-Anesthesia Care Unit (PACU) | immediately postoperatively | 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 |
| pain score at discharge from Post-Anesthesia Care Unit (PACU) | at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | 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 |
| pain score 24 hours postoperatively | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| remifentanil requirement during surgery | intraoperatively | dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value |
| number of participants experiencing side effects intraoperatively | intraoperatively | patients will be monitored for side-effects of the administered agents intraoperatively |
| number of participants experiencing side effects postoperatively | 48 hours postoperatively | patients will be monitored for side-effects of the administered agents postoperatively |
| time to first request for analgesia | during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | the time for the first patient request for analgesia will be noted |
| time to extubation | end of operation, approximately 1 hour after start of surgery | time from desflurane discontinuation to tracheal extubation |
| duration of nociception level<25 intraoperatively | intraoperatively | nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\<25 suggest adequate intraoperatively analgesia |
| time to emergence | end of operation, approximately 1 hour after start of surgery | time from desflurane discontinuation to first patient response (eye opening) |
| morphine consumption in Post-Anesthesia Care Unit (PACU) | immediately postoperatively | mg of morphine requested during patient PACU stay |
| pethidine consumption in the first 48 hours | 48 hours postoperatively | patients will be followed for cumulative pethidine consumption for 48 hours postoperatively |
Countries
Greece
Contacts
Primary ContactKASSIANI THEODORAKI, PhD, DESA
Outcome results
None listed