Postoperative Nausea and Vomiting (PONV)
Conditions
Keywords
postoperative nausea and vomiting, nausea, vomiting, laparoscopic cholecystectomy, superhydration, glucose 10%, dextrose 10%
Brief summary
The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. . The main questions it aims to answer are: Does Dextrose 10% or superhydration lower the number of times participants gets an episode of nausea and vomititng after laparoscopic cholecystectomy surgery? Researchers will compare Dextrose 10% versus superhydration to a placebo (a look-alike substance that contains no drug) to see if glucose 10% or superhydation can work to prevent postoperative nausea and vomiting. Participants will: Take Dextrose 10% or superhydration or a placebo in the operation monitored for 4 hours after surgery to check on their nausea and vomiting state
Interventions
DRUGringer lactate (20ml/kg)
ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively
DRUGDextrose 10%
Dextrose 10% 250 ml over 60 minutes
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 21- 60 years 2. Patients with ASA classification I and II
Exclusion criteria
1. Declining to give written informed consent. 2. Patients with morbid obesity (BMI \> 40). 3. ASA classification III-V. 4. Sever hypertension and heart failure. 5. Significant hepatic or renal disorder. 6. Patients with diagnosed diabetes mellitus type 1 or type 2. 7. Patients with history of PONV currently receiving steroids or antiemetics. 8. Pregnant or menstruating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of Post operative nausea and vomiting in the study treatment groups | Postoperative 4 hours stay in PACU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of vomiting episodes | Postoperative 4 hours stay in PACU | — |
| Measurement of PONV severity scores | Postoperative 4 hours stay in PACU | Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour |
| Time from extubation till discharge from PACU | From the moment of extubation till the moment of discharge from PACU with patient being completely vitally stable and nausea and vomiting free , assessed to be from 4 to 8 hours | — |
| total antiemetic medication consumption | Postoperative period 4 hours stay in PACU. ( if the patient needed to stay for longer duration in the PACU for any medical reason then any antiemetic used in this period will be recorded as well ) | Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour, Rescue antiemetic granisetron 1 mg IV was given when VDS scores were 2 or more. Medications were given only after excluding other causes of PONV such as hypovolemia, hypotension, hypoxia. The total number of doses of antiemetics used were obtained every half hour from the time of entry to the PACU for 4 hours |
Countries
Egypt
Outcome results
None listed