Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03548493

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: Magnesium sulphate Drug: Fentanyl Drug: Propofol	Phase 2

Detailed Description

Following institutional ethical committee approval, 34 patients undergoing burr-hole surgery for chronic subdural hemorrhage were included in this prospective, randomized, double-blind study.

Written informed consent were obtained from all subjects before enrollment in the study.

During the preanesthetic checkup,the operative procedure and anesthetic techniques were explained to all patients.

Upon arrival to operating theater, standard monitoring were applied to all patients and bispectral index was applied before starting the drug infusions and was used for maintenance of sedation during operation.

Subjects were randomized into 2 groups. Magnesium (M) group received Magnesium sulphate 50mg/kg IV over 15 minutes Followed by continuous infusion at 15 mg/kg/h Fentanyl (F) group received fentanyl 1 μg /kg IV bolus over 15 minutes Followed by continuous infusion starting at 0.5 μg /kg/h Loading and infusion doses of magnesium sulphate and loading doses of fentanyl were chosen from previous studies.

In both groups fentanyl and magnesium sulphate were accompanied by IV propofol at a dose of 50- 150 μg /kg/min bolus over 10 minutes to achieve target sedation level, that is, Ramsay sedation scale (RSS) 3, if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol were given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80 After achieving predefined target sedation level (RSS of 3), surgeons infiltrated the sites of the burrholes with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline infiltrated locally at least 5 minutes before surgical incision. After burr-hole craniotomy followed by the hematoma evacuation is accomplished, the Infusion of sedatives were discontinued just after placement of the final skin suture.

Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head were recorded. The first intervention is to attempt patient reassurance for 30 seconds. If movement continues then the bolus dose of propofol of 0.5 mg/kg was given and infusion dose was increased in the previously described manner till the maximum dose to regain BIS sedation score between 60-80.

If the patient starts to move again the same sequence was repeated. Induction of general anesthesia was deemed the final intervention in case satisfactory condition was not achieved within the rescue propofol.

All patients were transferred to the post-anesthesia care unit (PACU) after surgery.

The data collected are:

Total amount of Propofol consumption.
Total number of patient movements
The intraoperative and postoperative hemodynamic data
VAS (Visual analogue scale for pain) score
Time to first rescue analgesic
Adverse events
Surgeon satisfaction score was recorded.

Statistical analysis:

Data was analyzed using SPSS © Statistics version 23 (IBM© Corp., Armonk, NY, USA). Chi-square test (Fisher's exact test) was used to examine the relation between qualitative variables. For quantitative data, comparison between the two groups was done using independent sample t-test or Mann-Whitney test as appropriate. All tests were two-tailed. A p-value < 0.05 was considered significant.

Sample Size calculation:

A previous study reported that pre-procedure magnesium sulphate reduced the total propofol requirements to 130±19.09 mg compared to 172.8±29.09 mg with pre-procedure fentanyl. Based on these results, a sample size of 15 cases in each group was satisfactory to elicit the difference at an alpha level of 0.05 and a power of the test of 95%. The sample size was increased to 17 per group to compensate for possible dropouts.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

34 patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n=17) will receive magnesium sulphate adjuvant to propofol for sedation. Group B (n=17) will receive fentanyl adjuvant to propofol for sedation34 patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n=17) will receive magnesium sulphate adjuvant to propofol for sedation. Group B (n=17) will receive fentanyl adjuvant to propofol for sedation

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study

Actual Study Start Date :

Apr 10, 2018

Actual Primary Completion Date :

Aug 8, 2018

Actual Study Completion Date :

Aug 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Magnesium (M) group Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation	Drug: Magnesium sulphate Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h Drug: Propofol In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%
Active Comparator: Fentanyl (F) group Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation	Drug: Fentanyl Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h Drug: Propofol In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%

Arm

Intervention/Treatment

Experimental: Magnesium (M) group

Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation

Drug: Magnesium sulphate

Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h

Drug: Propofol

In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%

Active Comparator: Fentanyl (F) group

Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation

Drug: Fentanyl

Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h

Drug: Propofol

Outcome Measures

Primary Outcome Measures

Total amount of Propofol consumption in each group [From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery]
To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups

Secondary Outcome Measures

To measure the total number of intraoperative patient's movements [From the start of the surgery and throughout the duration of the surgery]
Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head
Heart rate [Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU]
Heart rate in beats/min
Non invasive blood pressure [Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU]
Systolic and diastolic blood pressure in mmhg
To assess surgeon satisfaction score [30 minutes after the end of the surgery]
Surgeon satisfaction was assessed as follows: 1, extremely dissatisfied; 2, not satisfied but able to manage; 3, satisfied; 4, extremely satisfied.
VAS score for pain [at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.]
The pain VAS is a unidimensional measure of pain intensity, the score is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Time to first rescue analgesic [During the first 24 hours in the postoperative period]
The time when the patient first requires analgesia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 50 years
ASA (American Society of Anesthesiologists physical status) grade I to II
Glasgow coma scale 14-15
Unilateral chronic subdural hematoma

Exclusion Criteria:

Hypertension (diastolic blood pressure > 160 mmHg)
Bradycardia (<50 bpm)
Ischemic heart disease (<6 months)
Second- or third-degree heart block
Long-term abuse of or addiction to alcohol, tobacco, opioids, and sedative-hypnotic drugs (>6 months)
Allergy to study drugs
Neuropsychiatric diseases
Predicted difficult airway according to Ganzouri score >4.
Patients with deviation in the surgical technique or with inadequacy of local anesthesia were excluded from the study.