Clinical trial NCT02169856: Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official title: A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Cholecystectomy
Laparoscopic
Postoperative Nausea and Vomiting
Lead sponsor: Benazir Bhutto Hospital, Rawalpindi
Sponsor class: OTHER_GOV
First posted: 2014-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
2. Patients with age range of 25 to 55 years

Exclusion Criteria:

1. H/O chronic illness like DM, IHD, CRF, CLD,
2. H/O acute or chronic psychiatric or psychological illness.
3. H/O APD (acid peptic disease) or regurgitation.
4. H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection.
5. H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month.
6. H/O alcohol intake in last one month.
7. Previous hepatobilliary surgery.
8. Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy.
9. Patients who are given opioids in postoperative period.
10. Patients who need epidural analgesia in postoperative period.

Primary outcomes:
measure: Postoperative nausea and vomiting.
timeFrame: will be measured at upto 15 hours postoperatively.
measure: Rescue antiemetic
timeFrame: It will be measured upto 15 hours postoperatively.
Secondary outcomes:
Other outcomes:
measure: age
timeFrame: age of the patient at study time in years. average was 30 years approximately.
Locations:
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital Rawalpindi.
state: Punjab
Study officials:
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Fazal H Shah, FCPS I
role: PRINCIPAL_INVESTIGATOR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Aurangzeb Khan, FCPS
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Jahangir S Khan, FCPS, FACS
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Muhammad B Habshi, FCPS I
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Muhammad Z Saeed, FCPS I
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Sheikh F Riaz, FCPS I
role: STUDY_CHAIR
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