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The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.
The primary outcome is the 1st 24 hours incidence of PONV
Other outcomes include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 0.5 mic/kg bolus | Active Comparator | selective alpha 2 adrenergic receptor agonist |
|
| dexmedetomidine 0.75 mic/kg bllus | Active Comparator | selective alpha 2 adrenergic receptor agonist |
|
| Placebo group | Placebo Comparator | receving equal volume of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride 0.5 mic/kg bolus | Drug | comparison between two bolus doses of dexmedetomidine with a placebo group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PONV in the 1st 24 hours postoperatively | The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries. | The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PONV attacks | Number of PONV attacks in the 1st 24 hours following Head and neck surgeries | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Pain score postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 11511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10485781 | Background | Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022. | |
| 23698545 | Result | Kim SH, Oh YJ, Park BW, Sim J, Choi YS. Effects of single-dose dexmedetomidine on the quality of recovery after modified radical mastectomy: a randomised controlled trial. Minerva Anestesiol. 2013 Nov;79(11):1248-58. Epub 2013 May 23. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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comparative study between two doses and a 3rd control group
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| Dexmedetomidine Hydrochloride 0.75 mic/kg bolus | Drug | comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron. |
|
| Placebo | Drug | equal volume of normal saline |
|
Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain
| The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Sedation score | using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Patient satisfaction | The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Blood pressure | Mean arterial blood pressure (MAP) in the 1st 24 hours | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Heart Rate (HR) | Pulse rate in the 1st 24 hours | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| The time to 1st call for rescue antiemetic | time to 1st call for rescue antiemetic and the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea | In the 1st 24 hours |
| The severity of nausea. | the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| Total amount of morphine consumption | morphine consumed in thw 1st 24 hours in milligrams. | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) |
| The time to 1st call for rescue analgesia | time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively | In the first 24 hours |
| D012816 | Signs and Symptoms |