Postoperative Nausea and Vomiting
Conditions
Brief summary
In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time
Detailed description
Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.
Interventions
PROCEDUREScalp block
Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.
OTHERControl Group
Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* ASA I and II patients, * aged 18 to 50 years, * 70-80 kg, * undergoing elective supratentorial craniotomy
Exclusion criteria
* patients under 18 years of age, * pregnancy, * emergency surgery, * patients with a Glasgow Coma Score (GCS) less than 15, * those with documented allergy to bupivacaine, * regular communication not possible, * Patients requiring prolonged mechanical ventilation (\> 2 hours after end of surgery) will be also excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PONV incidence & severity during the 1st 24 hours in ICU. | 24 hours | The intensity of the PONV was classified as: 0: without PONV, 1: nausea, 2: vomiting and 3: vomiting more than 2 times \[8\]. In addition, the incidence of PONV, the first time there was need for ondansetron and its total dose was recorded. With PONV score ≥ 2, the investigators used 4 mg ondansetron IV for antiemetic regimen. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Mean blood pressure in mmHg | 6 hours | Mean blood pressure will be measured at specific timing coded as follows: Tzero: mean blood pressure will be measured preoperatively as baseline T1: mean blood pressure will be measured after intubation T2: mean blood pressure will be measured after scalp block T3: mean blood pressure will be measured during pinning T4: mean blood pressure will be measured at skin incision Then mean blood pressure will be measured every 15 min for 1 hour, and every 1 hour till end of surgery T-end: mean blood pressure will be measured at skin closure |
| Total intraoperative fentanyl consumption in microgram | 6 hours | The bolus dose given at skin incision was not included |
| Recovery time in minutes | 10 minutes | It is the time interval between discontinuation of isoflurane and extubation |
| Intraoperative Heart rate as number of beats per minute | 6 hours | Heart rate will be measured at specific timing coded as follows: Tzero: Heart rate will be measured preoperatively as baseline T1: Heart rate will be measured after intubation T2: Heart rate will be measured after scalp block T3: Heart rate will be measured during pinning T4: Heart rate will be measured at skin incision Then Heart rate will be measured every 15 min for 1 hour, and every 1 hour till end of surgery T-end: Heart rate will be measured at skin closure |
Countries
Egypt
Outcome results
None listed