Postoperative Nausea and VomitingEFTNCT02169856
Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
A study testing EFTs (emotional freedom techniques), Tab. Midazolam 7.5 mg and Inj. Midazolam 0.7mg/kg in people with Postoperative Nausea and Vomiting, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- EFTs (emotional freedom techniques), Tab. Midazolam 7.5 mg and Inj. Midazolam 0.7mg/kg
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
- Patients with age range of 25 to 55 years
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Benazir Bhutto Hospital Rawalpindi.
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- 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
- Keywords
- Cholecystectomy, Laparoscopic, Postoperative Nausea and Vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFTs (emotional freedom techniques)Behavioural
Also called EFTs by garry craig
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
Tab. Midazolam 7.5 mgDrug
Also called Tab. Doramicum
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Inj. Midazolam 0.7mg/kgDrug
Also called inj. Doramicum
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
Inj. Propofol 2.5mg/kgDrug
It was given to induce anesthesia after 3 min of pre oxygenation.
Inj. Atracurium 0.5 mg/kgDrug
It was given to induce muscle relaxation during anesthesia
Sevoflurane 2.5 vol %Drug
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
Inj. Cefuroxime 1.5 g IVDrug
Also called inj. zinacef
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
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
Inj. Zantac 50mg IVDrug
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: It will be measured upto 15 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benazir Bhutto Hospital, Rawalpindi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi
- Investigators
- Fazal H Shah, FCPS I, Principal investigator, Benazir Bhutto Hospital, RawalpindiAurangzeb Khan, FCPS, Study chair, Benazir Bhutto Hospital, RawalpindiJahangir S Khan, FCPS, FACS, Study chair, Benazir Bhutto Hospital, RawalpindiMuhammad B Habshi, FCPS I, Study chair, Benazir Bhutto Hospital, RawalpindiMuhammad Z Saeed, FCPS I, Study chair, Benazir Bhutto Hospital, RawalpindiSheikh F Riaz, FCPS I, Study chair, Benazir Bhutto Hospital, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169856
- Sponsor's protocol ID
- 02
- Acronym
- EFT
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22619616Feng 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.
PubMed 19318293Bianchin 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.
PubMed 17589423Craig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf
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.
PubMed 22848802Church 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.
PubMed 23364126Church 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.
PubMed 22986277Stapleton 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.
PubMed 23984182
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT02169856
- Acronym / sponsor ID
- EFT / 02
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Cholecystectomy, Laparoscopic, Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benazir Bhutto Hospital, RawalpindiOther government
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | 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 IVcontrol 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 study group | Experimental | 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 IVEFTs (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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
- Patients with age range of 25 to 55 years
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFTs (emotional freedom techniques)Also: EFTs by garry craigThe 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 | Behavioural | EFTs study group |
| Tab. Midazolam 7.5 mgAlso: Tab. DoramicumTab. Midazolam 7.5 mg will be given to all patients at night before surgery. | Drug | EFTs study group, control group |
| Inj. Midazolam 0.7mg/kgAlso: inj. DoramicumInj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery. | Drug | EFTs study group, control group |
| Inj. Propofol 2.5mg/kgIt was given to induce anesthesia after 3 min of pre oxygenation. | Drug | EFTs study group, control group |
| Inj. Atracurium 0.5 mg/kgIt was given to induce muscle relaxation during anesthesia | Drug | EFTs study group, control group |
| Sevoflurane 2.5 vol %It was given to maintain anesthesia during surgery alongwith oxygen in air mixture | Drug | EFTs study group, control group |
| Inj. Cefuroxime 1.5 g IVAlso: inj. zinacefIt was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery | Drug | EFTs study group, control group |
| Drug: Inj. Ketorolac 30 mg IV3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period | Drug | EFTs study group, control group |
| Inj. Zantac 50mg IV2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery | Drug | EFTs study group, control group |
Primary outcome
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
- Background: PubMed 22619616Eryilmaz 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.
- Background: PubMed 19318293Feng 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.
- Background: PubMed 17589423Bianchin 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.
- BackgroundCraig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf
- Background: PubMed 22848802Church 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.
- Background: PubMed 23364126Church 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.
- Background: PubMed 22986277Church 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.
- Background: PubMed 23984182Stapleton 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.
- EFTs manualLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazal H Shah, FCPS I principal investigator
Benazir Bhutto Hospital, Rawalpindi
Aurangzeb Khan, FCPS study chair
Benazir Bhutto Hospital, Rawalpindi
Jahangir S Khan, FCPS, FACS study chair
Benazir Bhutto Hospital, Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFTs (emotional freedom techniques), Tab. Midazolam 7.5 mg and Inj. Midazolam 0.7mg/kg in people with Postoperative Nausea and Vomiting, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting. (time frame: will be measured at upto 15 hours postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02169856, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.