Postoperative Nausea and Vomiting Clinical Trial
Official title:
A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
In our study the investigators want to evaluate the effects of EFTs (emotional freedom
techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects
of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it
will be much valuable adjunct to postoperative management of the patients.
Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of
postoperative nausea and vomiting after laparoscopic cholecystectomy.
The laparoscopic cholecystectomy is now considered as the gold standard for gall stone
disease worldwide and over 90% of cholecystectomies are now performed laparoscopically. Due
to variety of factors, postoperative nausea and vomiting (PONV) which occurs in 40-70 % of
patients undergoing laparoscopic cholecystectomy (LC) is sometimes much troublesome to
manage. To reduce the incidence of PONV many drugs and modifications were introduced, such
as use of dexamethasone, serotonin receptor antagonists, changing drugs and dosages during
anesthesia and acupressure. All these measures except acupressure have some degree of side
effects on patients.
The Emotional Freedom Techniques (EFTs) which has been pioneered by Gary Craig is a form of
alternate medicine which works by tapping on body energy meridian points. Unlike drugs the
EFTs has no side effects too. The role of EFTs for various kinds of physical and mental
problems has been established and has shown quite significant results. Initially EFTs were
used for psychological benefits but later on research proved that it works on the physical
and biochemical levels too which is comparable to the various drugs which act by biochemical
changes on human body.
In our study we want to evaluate the effects of EFTs for reducing incidence of PONV. The
effects of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced
then it will be much valuable adjunct to postoperative management of the patients. We have
taken into the consideration of PONV only and after promising results we can evaluate EFTs
on more and more other aspects of patient management After meeting inclusion and exclusion
criteria, All patients were given Tab. Midazolam 7.5 mg PO at night before surgery and
received same standard general anesthesia with endotracheal intubation. Inj. Midazolam IV
0.7 mg/kg was given 45 min before surgery as premedication. Anesthesia was induced by
propofol (2.5 mg/kg) after 3 minutes of preoxygenation. Muscle relaxation was achieved by
atracuium (0.5 mg/kg). Anesthesia was maintained with sevoflurane (2.5 vol %) and oxygen in
air mixture (0.50 ratio). Ventilation was controlled mechanically and end tidal normocapnia
was maintained by keeping pCO2 at 35-38 mmHg.
Following medications were given to patients during the process.
- Inj. Cefuroxime 1.5 gm. IV (2 doses, 1st dose 30-60 min before surgery and 2nd dose 6
hours after surgery)
- Inj. Ketorolac 30mg IV (3 doses total, 1st dose immediate postop, 2nd and 3rd at 8 and
16 hours after surgery respectively)
- Inj. Zantac 50 mg IV (2 doses total, 1st immediate postop and 2nd at 12 hours after
surgery) All patients were operated by the consultant surgeons. After surgery ward all
patients received same standard postoperative care. At 6 hour postoperative period all
patients were assessed for PONV by VDS. Then patients were divided randomly into two
groups equally by consecutive non probability sampling. Group A was control group while
Group B received one session of EFTs tapping for 5 to 10 min. All patients were
assessed by PONV at 7, 10 and 15 hours postoperatively. Rescue antiemetic (inj.
Metoclopramide 10mg IV) was used when the score of PONV was 2 or more on VDS. To see
the effectiveness of EFTs in study group the no. of injections of metoclopramide were
not counted at 6 hour postoperatively i.e. before intervention of EFTs.
All the data was recorded on specially designed Performa. Statistical analysis: Data was
analyzed using SPSS version 12. Mean and standard deviation were calculated for quantitative
data like age, frequency of antiemetic injections. Frequency and percentages were calculated
for qualitative data like gender, PONV on the basis of VDS scale. The results were finally
analyzed and compared for the two groups using Chi-square test and Mann Whitney U tests
where applicable. A p value <0.05 was considered significant.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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