1. Dr. Mohamed AlKhayarine
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   
A Comparison of Two Different Doses of Intrathecal Fentanyl: BIS and Clinical Study
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    
Dr. Hamdy Shokr
Dr. Mohamed El Arief
Dr. Mohamed AlKhayarine
Dr. Mohamedd Soliman ⏏
⏏ I am going to present our project about comparison of 2 different doses12.5 & 25 mcg of intrathecal fentanyl using both clinical and Bispectral Index monitoring

2. The Rational  Adding fentanyl to LAs is a common practice
 Enhance and prolong the sensory blockade
 Reported to induce sedation even without use
of systemic sedatives
 Different mechanisms of sedation had been
reported
⏏ In anaesthesia practice, Adding fentanyl into a cocktails of local anesthetics for spinal anaesthesia is a common daily practice used to enhance and prolong the sensory block and it has been reported to induce sedation even without use of systemic sedatives
Usage of local anesthetics alone for neuraxial block could reduce the patients’ requirements of inhalation and sedative anesthetic agents.
⏏ The profound spinal sensory block or peripheral deafferentation is claimed to decrease sensory input to the reticular activating system (RAS) and decrease cortical arousal degree suggesting a possible mechanism of sedation.
⏏ High sensory level, as commonly accompanied with hemodynamic instability with cerebral hypoperfusion had been reported to induce significant sedation.
⏏ Also can be explained by direct rostral spread of intrathecal narcotics

3. Background  Evaluation and comparing the possible
sedative effect of two different doses of
intrathecal fentanyl
 In unpremeditated patients
 In lower limbs orthopedic surgery
 Using the Ramsay sedation score and
Bispectral Index (BIS) monitoring
⏏ The aim of this study was to evaluate and compare the possible sedative effect of 2 different doses intrathecal fentanyl in unpremeditated patients undergoing lower extremity orthopedic surgery by using the Ramsay sedation score as a subjective clinical monitor and Bispectral Index (BIS) as an objective monitoring.

4. Material and Methods  A prospective, randomized, double-blinded
 After obtaining informed consents
 90 patients undergoing LL orthopedic surgery
 3 equal groups (SAB)
 G1  bupi 12.5 mg + 0.5ml Saline
 G2  bupi 12.5 mg mcg fentanyl
 G3  bupi 12.5 mg + 25 mcg fentanyl
⏏ This study was prospective, randomized, double-blinded done in Hamad General main theater, we have randomly assigned 90 patients undergoing lower extremities orthopedic surgery allocated into three equal groups. Each group had received subarachnoid anesthesia in the form of hyperbaric bupivacaine 12.5 mg with either normal saline (G1), fentanyl 12.5 mcg (G2), or fentanyl 25 mcg (G3) within a total volume of 3 ml for all groups .
The primary end point was the level of the consciousness and the level of sedation. Bispectral index (BIS) values, Ramsay sedation score and standard physiological monitoring were recorded before and for 120 minutes after subarachnoid block at 10-minute intervals. The sensory block level was assessed every 5 minutes up to 30 minutes after injection. The patient satisfaction was evaluated postoperatively using surveys analyzed by Likert scale and narrative descriptors.

5. Material and Methods  The primary end point
 objective : BIS guided Level of Consciousness
 Subjective: Clinical assessment for Level of
Sedation
 Monitoring
 BIS Monitor
 Ramsay Sedation Score
 Standard Monitoring
 Side effect Monitoring
⏏ our primary end point was to assess level of consciousness objectively by continuous monitoring of BIS values , as well as assessing patient sedation level clinically.
⏏ Mean arterial pressure, heart rate, Oxygen saturation, nasal end-tidal CO2 and respiratory rate were recorded every 5 min. until the sensory block level stablished and every 10 min. afterwards throughout the study.
⏏ possible side effects of intrathecal narcotics such as pruritus, nausea, and vomiting, hypotension or oxygen desaturation had been recorded perioperatively , as well as micturition difficulty for 24 hours .
⏏ Monitoring of sedation can be achieved clinically by a subjective Ramsay sedation score, (OAA/S) and by using objective monitoring such as BIS recorded every 10 min for two hours study period after SAB .

6. Statistical Analysis  Sample size was determined with a statistician
 Data was analyzed by using SPSS version 18.
 P value of 0.05 or less was considered as
statistical significance level.

7. Results   
⏏ Our results showed no significant differences between the three groups as regards demographic variables, duration of surgery and the level of sensory block (at 30 min after SAB).

8. Results   
⏏ This study presented dose related reduction in mean Bispectral index (BIS) values in G2 & 3 compared to baseline.
⏏ As shown in this graph, the onset of significant reduction in both groups II &III had been started at 30 min from SAB, and continued for 50 min in GII and 70 min in GIII.

9. Results   
⏏ We recorded significant increase in clinical sedation levels compared to baseline after 20 min from SAB and extended for 1 hour in both fentanyl groups (GII) & (GIII) in comparison to non fentanyl group (I) , as reflected by Ramsay sedation score and this difference was insignificant between GII and III throughout all different time points .

10. Results   
⏏ In all 3 groups, the mean arterial pressure was significantly decreased to an average of less than 20% from baseline values, with no significant differences among the three groups and without any indication for active management

11. Results  Mild to moderate pruritus  GII 36.7% (11)  GIII 43.3% (13)
 No bradycardia, bradypnea
 No oxygen desaturation or postop
urinary retention
Mild to moderate pruritus occurred in (11) 36.7% and (13) 43.3% of patients in groups II and III respectively with no significant difference in the incidence between both groups.
⏏ While, None of the patients suffered from bradycardia, bradypnea below 12 breaths/min, oxygen desaturation or postoperative urinary retention.

12. Conclusion    
As indicated by BIS index, adding fentanyl to bupivacaine induces more sedative effect than using bupivacaine alone, and this effect was more by adding 25 mcg fentanyl to bupivacaine for spinal anesth.

13. Questions ?

14. Thank You