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

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ClinicalTrials.gov Identifier: NCT02169856
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi

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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
Study Start Date : July 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
control group

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
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Other Name: Tab. Doramicum

Drug: Inj. Midazolam 0.7mg/kg
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Other Name: inj. Doramicum

Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.

Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia

Drug: Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

Drug: Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Other Name: inj. zinacef

Drug: Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period

Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

Experimental: EFTs study group

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)
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
Other Name: EFTs by garry craig

Drug: Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Other Name: Tab. Doramicum

Drug: Inj. Midazolam 0.7mg/kg
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Other Name: inj. Doramicum

Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.

Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia

Drug: Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

Drug: Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Other Name: inj. zinacef

Drug: Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period

Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery




Primary Outcome Measures :
  1. Postoperative nausea and vomiting. [ Time Frame: will be measured at upto 15 hours postoperatively. ]

    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

    1. Mild nausea
    2. Moderate nausea
    3. Frequent vomiting
    4. Severe vomiting

  2. Rescue antiemetic [ Time Frame: It will be measured upto 15 hours postoperatively. ]
    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).


Other Outcome Measures:
  1. age [ Time Frame: age of the patient at study time in years. average was 30 years approximately. ]
    age of the patient



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169856


Locations
Layout table for location information
Pakistan
Benazir Bhutto Hospital Rawalpindi.
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Benazir Bhutto Hospital, Rawalpindi
Investigators
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Principal Investigator: Fazal H Shah, FCPS I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Aurangzeb Khan, FCPS Benazir Bhutto Hospital, Rawalpindi
Study Chair: Jahangir S Khan, FCPS, FACS Benazir Bhutto Hospital, Rawalpindi
Study Chair: Muhammad B Habshi, FCPS I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Muhammad Z Saeed, FCPS I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Sheikh F Riaz, FCPS I Benazir Bhutto Hospital, Rawalpindi

Publications:
Craig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf

Layout table for additonal information
Responsible Party: Dr.Fazal hussain Shah, Resident Surgery, Benazir Bhutto Hospital, Rawalpindi
ClinicalTrials.gov Identifier: NCT02169856     History of Changes
Other Study ID Numbers: 02
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi:
Cholecystectomy
Laparoscopic
Postoperative Nausea and Vomiting

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Propofol
Midazolam
Sevoflurane
Atracurium
Ranitidine
Ranitidine bismuth citrate
Ketorolac
Ketorolac Tromethamine
Cefuroxime
Cefuroxime axetil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents