Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol for Monitored Anesthesia Care During Burr-hole Surgery for Chronic Subdural Hematoma: Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- average systolic blood pressure
Study Overview
Brief Summary
MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. No study, to the best of our knowledge had evaluated fentanyl continuous infusion, nor MgSo4 infusion as adjuvant sedative agents to propofol during Burr-hole surgery. The aim of this study is to evaluate and compare MgSO4 versus fentanyl continuous infusions for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural hematoma with local infiltration.
Detailed Description
All participants or their proxy will be informed about the anesthetic techniques and the operative procedure and will provide written informed consent before enrollment in the study.
The eligible patients will be randomly divided by computer designed lists and then will be concealed in closed envelopes into the two study groups. A research assistant who will not be involved in patient management will be responsible for opening the envelope, group assignment and drugs preparation.
Anesthetic management Pre-induction No premedication will be administered. Upon arrival to the operating theater, an intravenous (IV) cannula will be placed, and standard monitors, including 5-lead electrocardiogram, noninvasive arterial blood pressure monitor, and pulse oximetry, will be applied. Oxygen supplementation at fraction of inspired oxygen (FiO2) of 0.35 will be achieved through a suitable air entrainment mask. Bispectral index (BIS: apparatus info) will be applied before starting the drug infusions and will be used for maintenance of sedation during operation.
Induction of anesthesia Group M (n=17): will receive a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution Group F (n=17): will receive a loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution Both groups will be given 0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80.
Intraoperative management After achieving the target sedation level (RSS of 3), surgeons will infiltrate the surgical site with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline at least 5 minutes before surgical incision. After performing burr-hole craniotomy soaked pledgets with lidocaine will be applied to anaesthetize the dura, the dura will be then opened, and the hematoma will be evacuated. The Infusion of sedatives will be ceased after skin closure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with unilateral, chronic subdural hematoma,
- •aged above 50 years,
- •american society of anesthesiologist-physical status (ASA-PS) grade I-II,
- •Glasgow coma scale of 14-15.
Exclusion Criteria
- •Patients with hypertension (Systolic blood pressure > 160 mmHg),
- •bradycardia (<50 bpm),
- •ischemic heart disease,
- •second- or third-degree heart block,
- •long-term abuse of or addiction to opioids, and sedative-hypnotic drugs (>6 months),
- •allergy to study drugs
- •neuropsychiatric diseases
- •patients with predicted difficult airway
- •patients with history of obstructive sleep apnea
- •patients with deviation in the surgical technique
- •inadequacy of local anesthesia
Arms & Interventions
Group M
magnesium sulphate as adjuvant to propofol
Intervention: Magnesium Sulphate (Drug)
Group M
magnesium sulphate as adjuvant to propofol
Intervention: Propofol (Drug)
Group F
fentanyl as adjuvant to propofol
Intervention: Fentanyl (Drug)
Group F
fentanyl as adjuvant to propofol
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
average systolic blood pressure
Time Frame: after induction of conscious sedation till end of procedure
mmgh
Secondary Outcomes
- Total amount of Propofol consumption(after induction of conscious sedation till end of procedure)
- atropine use(after induction of conscious sedation till end of procedure)
- ephedrine use(after induction of conscious sedation till end of procedure)
- Total number of intraoperative patient's movements(after induction of conscious sedation till end of procedure)
- Diastolic blood pressure(upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU)
- Surgeon satisfaction score(30 minutes after the end of the surgery)
- Visual Analogue Scale (VAS) for pain(at 15 minutes, 30 minutes, 1hr, 2 hrs. 3hrs and 6 hrs after PACU admission)
- Systolic blood pressure(upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU)
- Heart rate(upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU)
- first rescue analgesic during 1 hour post operative(1 hour postoperative)
- Ramsay sedation scale(15 and 30 minutes postoperative)
- postoperative nausea and vomiting(first 24 hours in the postoperative period)
Investigators
Maha Mostafa Ahmad, MD
Lecturer of Anesthesia, surgical intensive care and pain mangement
Kasr El Aini Hospital