Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Behavioral: EFTs (emotional freedom techniques)
* Drug: Tab. Midazolam 7.5 mg
* Drug: Inj. Midazolam 0.7mg/kg
* Drug: Inj. Propofol 2.5mg/kg
* Drug: Inj. Atracurium 0.5 mg/kg
* Drug: Sevoflurane 2.5 vol %
* Drug: Inj. Cefuroxime 1.5 g IV
* Drug: Drug: Inj. Ketorolac 30 mg IV
* Drug: Inj. Zantac 50mg IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective laparoscopic cholecystectomy for gallstone disease. Patients with age range of 25 to 55 years Exclusion Criteria: H/O chronic illness like DM, IHD, CRF, CLD, H/O acute or chronic psychiatric or psychological illness. H/O APD (acid peptic disease) or regurgitation. H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection. H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month. H/O alcohol intake in last one month. Previous hepatobilliary surgery. Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy. Patients who are given opioids in postoperative period. Patients who need epidural analgesia in postoperative period.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br>control group was not given any EFTs (emotional freedom techniques) therapy for postoperative nausea and vomiting. Following medications were given to both groups. details are in respective interventions. Tab. Midazolam 7.5 mg Inj. Midazolam IV 0.7 mg/kg inj. propofol (2.5 mg/kg) inj. atracuium (0.5 mg/kg). sevoflurane (2.5 vol %) oxygen in air mixture (0.50 ratio) Inj. Cefuroxime 1.5 gm. IV Inj. Ketorolac 30mg IV Inj. Zantac 50 mg IV inj. Metoclopramide 10mg IV | Drug: Tab. Midazolam 7.5 mg<br>* Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.<br>* Other names: Tab. Doramicum;Drug: Inj. Midazolam 0.7mg/kg<br>* Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.<br>* Other names: inj. Doramicum;Drug: Inj. Propofol 2.5mg/kg<br>* It was given to induce anesthesia after 3 min of pre oxygenation.<br>Drug: Inj. Atracurium 0.5 mg/kg<br>* It was given to induce muscle relaxation during anesthesia<br>Drug: Sevoflurane 2.5 vol %<br>* It was given to maintain anesthesia during surgery alongwith oxygen in air mixture<br>Drug: Inj. Cefuroxime 1.5 g IV<br>* It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery<br>* Other names: inj. zinacef;Drug: Drug: Inj. Ketorolac 30 mg IV<br>* 3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period<br>Drug: Inj. Zantac 50mg IV<br>* 2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery<br>|
| Experimental: EFTs study group<br>EFTs (emotional freedom techniques) was applied to the patietns. one session of 5 to 10 min at 6 hours postoperatively. Following medications were given to both groups. details are in respective interventions. Tab. Midazolam 7.5 mg Inj. Midazolam IV 0.7 mg/kg inj. propofol (2.5 mg/kg) inj. atracuium (0.5 mg/kg). sevoflurane (2.5 vol %) oxygen in air mixture (0.50 ratio) Inj. Cefuroxime 1.5 gm. IV Inj. Ketorolac 30mg IV Inj. Zantac 50 mg IV inj. Metoclopramide 10mg IV | Behavioral: EFTs (emotional freedom techniques)<br>* 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<br>* Other names: EFTs by garry craig;Drug: Tab. Midazolam 7.5 mg<br>* Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.<br>* Other names: Tab. Doramicum;Drug: Inj. Midazolam 0.7mg/kg<br>* Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.<br>* Other names: inj. Doramicum;Drug: Inj. Propofol 2.5mg/kg<br>* It was given to induce anesthesia after 3 min of pre oxygenation.<br>Drug: Inj. Atracurium 0.5 mg/kg<br>* It was given to induce muscle relaxation during anesthesia<br>Drug: Sevoflurane 2.5 vol %<br>* It was given to maintain anesthesia during surgery alongwith oxygen in air mixture<br>Drug: Inj. Cefuroxime 1.5 g IV<br>* It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery<br>* Other names: inj. zinacef;Drug: Drug: Inj. Ketorolac 30 mg IV<br>* 3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period<br>Drug: Inj. Zantac 50mg IV<br>* 2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting. | Both groups will be assessed for postoperative nausea/vomiting by VDS (verbal descriptive scale) at 6, 7, 10 and 15 hours respectively. Verbal descriptive Scale 0 No nausea Mild nausea Moderate nausea Frequent vomiting Severe vomiting | will be measured at upto 15 hours postoperatively. | 
| Rescue antiemetic | Both groups will receive rescue antiemetic i.e. inj. Metoclopramide 10mg IV when there will be 2 or more score on VDS (verbal descriptive scale). | It will be measured upto 15 hours postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy, Laparoscopic, Postoperative Nausea and Vomiting