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the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BF | Experimental | hyperbaric Bupivacaine 10mg with fentanyl 10micrograms |
|
| Group BD | Experimental | hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine, fentanyl | Drug | Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time till T10 dermatome achieved (Sec) | Spinal block characteristics | Post operative initial hour |
| Time of maximum bromage achieved (Sec) | Spinal block characteristics | Post operative initial hour |
| Regression time to T10 dermatome (Min) | Spinal block characteristics | Post operative initial hour |
| Time of complete motor recovery (Min) | Spinal block characteristics | Post operative initial hour |
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 1 hour |
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 2 hour |
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 3 hour |
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 4 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | Sensation to throw out stomach contents | 24 hours Post operative |
| Vomiting | Act of throwing out stomach contents through mouth |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Hemodynamics | Baseline |
| Systolic Blood Pressure | Hemodynamics | Immediate after giving intrathecal injection and positoning |
Inclusion Criteria:
Term pregnancy Singleton ASA I and II, BMI <35, elective C/section
Exclusion Criteria:
patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civil Hospital Karachi | Karachi | Sindh | 75520 | Pakistan | ||
| DUHS, Civil hospital Karachi (CHK) |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Randomize controlled trial (RCT)
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Patients were randomly allocated into two groups and will be blinded to the study drugs. The drugs will be chosen by seal envelope method by principal investigator and co-investigator. The drugs will be filled in the syringes and the syringes handed over to on floor consultant anesthetist who are blinded to the study.
| Bupivacaine, dexmedetomidine |
| Drug |
Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms |
|
| 24 hours Post operative |
| Pruritus | Unpleasing sensation on the skin that provokes to scratch | 24 hours Post operative |
| Respiratory distress | Difficulty in breathing | 24 hours Post operative |
| Shivering | The act of shaking slightly and uncomfortably due to felling of cold temperature | 24 hours Post operative |
| Bradycardia | Heat rate less than <60 bpm | 24 hours Post operative |
| Hypotension | Decrease in BP greater than 20% of baseline | 24 hours Post operative |
| Systolic Blood Pressure | Hemodynamics | at 5 minute |
| SBP | Hemodynamics | at 10 minute |
| Systolic Blood Pressure | Hemodynamics | at 15 minute |
| Systolic Blood Pressure | Hemodynamics | at 20 minute |
| Diastolic Blood Pressure | Hemodynamics | Baseline |
| Diastolic Blood Pressure | Hemodynamics | Immediate after giving intrathecal injection and positoning |
| Diastolic Blood Pressure | Hemodynamics | at 5 minute |
| Diastolic Blood Pressure | Hemodynamics | at 10 minute |
| Diastolic Blood Pressure | Hemodynamics | at 15 minute |
| Diastolic Blood Pressure | Hemodynamics | at 20 minute |
| Heart Rate | Hemodynamics | Baseline |
| Heart Rate | Hemodynamics | Immediate after giving intrathecal injection and positoning |
| Heart Rate | Hemodynamics | at 5 minute |
| Heart Rate | Hemodynamics | at 10 minute |
| Heart Rate | Hemodynamics | at 15 minute |
| Heart Rate | Hemodynamics | at 20 minute |
| oxygen saturation | Hemodynamics | Baseline |
| oxygen saturation | Hemodynamics | Immediate after giving intrathecal injection and positoning |
| oxygen saturation | Hemodynamics | at 5 minute |
| oxygen saturation | Hemodynamics | at 10 minute |
| oxygen saturation | Hemodynamics | at 15 minute |
| oxygen saturation | Hemodynamics | at 20 minute |
| respiratory rate | Hemodynamics | Baseline |
| respiratory rate | Hemodynamics | Immediate after giving intrathecal injection and positoning |
| respiratory rate | Hemodynamics | at 5 minute |
| respiratory rate | Hemodynamics | at 10 minute |
| respiratory rate | Hemodynamics | at 15 minute |
| respiratory rate | Hemodynamics | at 20 minute |
| Karachi |
| Sindh |
| 75520 |
| Pakistan |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |