Head and Neck Surgeries, Postoperative Nausea and Vomiting
Conditions
Keywords
Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting
Brief summary
The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
Detailed description
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: * Time to 1st call for rescue antiemetic and the total amount of antiemetics * Number of PONV attacks * Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia * Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S) * Patient satisfaction * Vital signs in the 1st 24 hours
Interventions
DRUGDexmedetomidine Hydrochloride 0.5 mic/kg bolus
comparison between two bolus doses of dexmedetomidine with a placebo group
DRUGDexmedetomidine Hydrochloride 0.75 mic/kg bolus
comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
DRUGPlacebo
equal volume of normal saline
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
comparative study between two doses and a 3rd control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV ) * Head and neck surgeries in adults * ASA ( I , II )
Exclusion criteria
* Patients on ( steroids , antiemetics or any drug caude emesis ) * Any active cardiac condition at the time of the surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PONV in the 1st 24 hours postoperatively | The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score postoperatively. | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain |
| Sedation score | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert |
| Patient satisfaction | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied |
| Blood pressure | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | Mean arterial blood pressure (MAP) in the 1st 24 hours |
| Number of PONV attacks | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | Number of PONV attacks in the 1st 24 hours following Head and neck surgeries |
| The time to 1st call for rescue antiemetic | In the 1st 24 hours | 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 |
| The severity of nausea. | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea |
| Total amount of morphine consumption | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | morphine consumed in thw 1st 24 hours in milligrams. |
| The time to 1st call for rescue analgesia | In the first 24 hours | time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively |
| Heart Rate (HR) | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | Pulse rate in the 1st 24 hours |
Countries
Egypt
Outcome results
None listed