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This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone | Active Comparator | Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. |
|
| normal saline | Placebo Comparator | Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | active comparator |
| |
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex | measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes) | minutes after administration of sugammadex (0 to 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Assessed by Numeric Rating Scale 0-10 | 1, 6, 12, 24 hours postoperatively |
| Postoperative nausea and vomiting | Assessed by nausea/vomiting scale (11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from end of surgery to extubation of patient | measurement of time after administration of the reversal agent (sugammadex) to achieve extubation of patient (up to 30 minutes) | minutes after administration of sugammadex (0 to 30 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str. | Athens | 12462 | Greece |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
placebo controlled intervention |
|
|
| sugammadex | Drug | sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery |
|
| 1, 6, 12, 24 hours postoperatively |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |