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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
EFTs (emotional freedom techniques)
Tab. Midazolam 7.5 mg
Inj. Midazolam 0.7mg/kg
Inj. Propofol 2.5mg/kg
Inj. Atracurium 0.5 mg/kg
Sevoflurane 2.5 vol %
Inj. Cefuroxime 1.5 g IV
Drug: Inj. Ketorolac 30 mg IV
Inj. Zantac 50mg IV
Sponsored by
Benazir Bhutto Hospital, Rawalpindi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Cholecystectomy, Laparoscopic, Postoperative Nausea and Vomiting

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Benazir Bhutto Hospital Rawalpindi.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

EFTs study group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
June 9, 2014
Last Updated
June 19, 2014
Sponsor
Benazir Bhutto Hospital, Rawalpindi
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1. Study Identification

Unique Protocol Identification Number
NCT02169856
Brief Title
Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Acronym
EFT
Official Title
A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benazir Bhutto Hospital, Rawalpindi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Cholecystectomy, Laparoscopic, Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
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
Arm Title
EFTs study group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
EFTs (emotional freedom techniques)
Other Intervention Name(s)
EFTs by garry craig
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Tab. Midazolam 7.5 mg
Other Intervention Name(s)
Tab. Doramicum
Intervention Description
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Intervention Type
Drug
Intervention Name(s)
Inj. Midazolam 0.7mg/kg
Other Intervention Name(s)
inj. Doramicum
Intervention Description
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Intervention Type
Drug
Intervention Name(s)
Inj. Propofol 2.5mg/kg
Intervention Description
It was given to induce anesthesia after 3 min of pre oxygenation.
Intervention Type
Drug
Intervention Name(s)
Inj. Atracurium 0.5 mg/kg
Intervention Description
It was given to induce muscle relaxation during anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane 2.5 vol %
Intervention Description
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
Intervention Type
Drug
Intervention Name(s)
Inj. Cefuroxime 1.5 g IV
Other Intervention Name(s)
inj. zinacef
Intervention Description
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Intervention Type
Drug
Intervention Name(s)
Drug: Inj. Ketorolac 30 mg IV
Intervention Description
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period
Intervention Type
Drug
Intervention Name(s)
Inj. Zantac 50mg IV
Intervention Description
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting.
Description
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
Time Frame
will be measured at upto 15 hours postoperatively.
Title
Rescue antiemetic
Description
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).
Time Frame
It will be measured upto 15 hours postoperatively.
Other Pre-specified Outcome Measures:
Title
age
Description
age of the patient
Time Frame
age of the patient at study time in years. average was 30 years approximately.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazal H Shah, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aurangzeb Khan, FCPS
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jahangir S Khan, FCPS, FACS
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Muhammad B Habshi, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Muhammad Z Saeed, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sheikh F Riaz, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
Facility Information:
Facility Name
Benazir Bhutto Hospital Rawalpindi.
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22619616
Citation
Eryilmaz HB, Memis D, Sezer A, Inal MT. The effects of different insufflation pressures on liver functions assessed with LiMON on patients undergoing laparoscopic cholecystectomy. ScientificWorldJournal. 2012;2012:172575. doi: 10.1100/2012/172575. Epub 2012 Apr 24.
Results Reference
background
PubMed Identifier
19318293
Citation
Feng PH, Chu KS, Lu IC, Shieh JP, Tzeng JI, Ho ST, Wang JJ, Chu CC. Haloperidol plus ondansetron prevents postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Acta Anaesthesiol Taiwan. 2009 Mar;47(1):3-9. doi: 10.1016/S1875-4597(09)60013-8.
Results Reference
background
PubMed Identifier
17589423
Citation
Bianchin A, De Luca A, Caminiti A. Postoperative vomiting reduction after laparoscopic cholecystectomy with single dose of dexamethasone. Minerva Anestesiol. 2007 Jun;73(6):343-6.
Results Reference
background
Citation
Craig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf
Results Reference
background
PubMed Identifier
22848802
Citation
Church D, De Asis MA, Brooks AJ. Brief group intervention using emotional freedom techniques for depression in college students: a randomized controlled trial. Depress Res Treat. 2012;2012:257172. doi: 10.1155/2012/257172. Epub 2012 Jul 17.
Results Reference
background
PubMed Identifier
23364126
Citation
Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351.
Results Reference
background
PubMed Identifier
22986277
Citation
Church D, Yount G, Brooks AJ. The effect of emotional freedom techniques on stress biochemistry: a randomized controlled trial. J Nerv Ment Dis. 2012 Oct;200(10):891-6. doi: 10.1097/NMD.0b013e31826b9fc1.
Results Reference
background
PubMed Identifier
23984182
Citation
Stapleton P, Church D, Sheldon T, Porter B, Carlopio C. Depression symptoms improve after successful weight loss with emotional freedom techniques. ISRN Psychiatry. 2013 Jul 28;2013:573532. doi: 10.1155/2013/573532. eCollection 2013.
Results Reference
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Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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