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

June 19, 2014 updated by: Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Benazir Bhutto Hospital Rawalpindi.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Tab. Doramicum
Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
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 Names:
  • inj. zinacef
Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Drug: Inj. Midazolam 0.7mg/kg
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Other Names:
  • inj. Doramicum
Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia
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
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
Drug: Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Other Names:
  • Tab. Doramicum
Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
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 Names:
  • inj. zinacef
Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Drug: Inj. Midazolam 0.7mg/kg
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Other Names:
  • inj. Doramicum
Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia
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
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 Names:
  • EFTs by garry craig

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
will be measured at upto 15 hours postoperatively.
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).
It will be measured upto 15 hours postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
age
Time Frame: age of the patient at study time in years. average was 30 years approximately.
age of the patient
age of the patient at study time in years. average was 30 years approximately.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benazir Bhutto Hospital, Rawalpindi

Investigators

  • Study Chair: Aurangzeb Khan, FCPS, Benazir Bhutto Hospital, Rawalpindi
  • Principal Investigator: Fazal H Shah, FCPS I, 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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