NCT02169856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 9, 2014

Last Update Submit

June 19, 2014

Conditions

Postoperative Nausea and Vomiting

Keywords

CholecystectomyLaparoscopicPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

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

Other Outcomes (1)

  • age

    age of the patient at study time in years. average was 30 years approximately.

Study Arms (2)

control group

OTHER

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 mgDrug: Inj. Midazolam 0.7mg/kgDrug: Inj. Propofol 2.5mg/kgDrug: Inj. Atracurium 0.5 mg/kgDrug: Sevoflurane 2.5 vol %Drug: Inj. Cefuroxime 1.5 g IVDrug: Drug: Inj. Ketorolac 30 mg IVDrug: Inj. Zantac 50mg IV

EFTs study group

EXPERIMENTAL

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)Drug: Tab. Midazolam 7.5 mgDrug: Inj. Midazolam 0.7mg/kgDrug: Inj. Propofol 2.5mg/kgDrug: Inj. Atracurium 0.5 mg/kgDrug: Sevoflurane 2.5 vol %Drug: Inj. Cefuroxime 1.5 g IVDrug: Drug: Inj. Ketorolac 30 mg IVDrug: Inj. Zantac 50mg IV

Interventions

EFTs (emotional freedom techniques)BEHAVIORAL

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

Also known as: EFTs by garry craig
EFTs study group
Tab. Midazolam 7.5 mgDRUG

Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.

Also known as: Tab. Doramicum
EFTs study groupcontrol group
Inj. Midazolam 0.7mg/kgDRUG

Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.

Also known as: inj. Doramicum
EFTs study groupcontrol group
Inj. Propofol 2.5mg/kgDRUG

It was given to induce anesthesia after 3 min of pre oxygenation.

EFTs study groupcontrol group
Inj. Atracurium 0.5 mg/kgDRUG

It was given to induce muscle relaxation during anesthesia

EFTs study groupcontrol group
Sevoflurane 2.5 vol %DRUG

It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

EFTs study groupcontrol group
Inj. Cefuroxime 1.5 g IVDRUG

It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery

Also known as: inj. zinacef
EFTs study groupcontrol group
Drug: Inj. Ketorolac 30 mg IVDRUG

3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period

EFTs study groupcontrol group
Inj. Zantac 50mg IVDRUG

2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

EFTs study groupcontrol group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital Rawalpindi.

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (8)

  • 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.

    PMID: 22619616BACKGROUND

  • 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.

    PMID: 19318293BACKGROUND

  • 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.

    PMID: 17589423BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 22848802BACKGROUND

  • 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.

    PMID: 23364126BACKGROUND

  • 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.

    PMID: 22986277BACKGROUND

  • 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.

    PMID: 23984182BACKGROUND

Related Links

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Fazal H Shah, FCPS I

    Benazir Bhutto Hospital, Rawalpindi

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Surgery

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 23, 2014

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

PA(1)