Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone
Brief summary
The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in women scheduled for gynecologic laparoscopic surgery with general anesthesia.
Detailed description
150 female patients, aged between 18 to 60 y, who are scheduled for elective gynecological laparoscopic surgery requiring general anesthesia, will be randomly allocated by a computer generated randomization table to acustimulation group (Group Acu), tropisetron group (Group Trp),or dexamethasone group (Group Dxm). In Group Acu, a surface electrode will be applied in the induction room to the P6 acupoint 30 min before induction.An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold.The stimulation will be maintained until the patient is discharged from the post-anesthesia care unit (PACU). In Group Trp and Group Dxm, the same protocol will be applied unless silicone covers attached to both electrodes. A standardized anesthetic protocol will be followed. After induction, dexamethasone 10mg i.v. will be given in all groups. All patients will receive intravenous lactated Ringer's solution based on calculated preoperative deficits, surgical procedure, and estimated intraoperative blood loss. Parecoxib 40mg i.v. during surgery and incision infiltration of 0.5% ropivacaine at the end of surgery will be used for post-operative analgesia. After surgery, analgetic therapy will continue with morphine upon patient's request.After extubation, patients will be transported to PACU and observed for no less than 30 min. Metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication. At the start of skin closure, a prefilled syringe which contains 5 ml of a solution will be administered intravenously to the patient. It will contain either saline (Group Acu and Group Dxm) or tropisetron 5mg (Group Trp).The syringe with the drug will be prepared by a study coordinator according to group allocation. The patients, the anesthesiologists, and the nursing staff shall be unaware of the group assignments. An anesthesiologist and an anesthetic nurse, who are trained for the study and blinded to the randomization, will collect the data.
Interventions
DEVICETranscutaneous electrical acupoint stimulation
A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
DRUGTropisetron
will be given at the start of skin closure
DRUGDexamethasone
will be given after induction
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I or II * aged between 18 to 60yr * scheduled for elective gynecological laparoscopic surgery requiring general anesthesia
Exclusion criteria
* pregnancy or breastfeeding * mental retardation * psychiatric or neurological disease * use of antiemetics, emetogenic drugs, opioids or glucocorticosteroids within 3 days prior to surgery * known allergy to tropisetron or dexamethasone * nausea and/or vomiting within 24 hr prior to surgery * implantation of a cardiac pacemaker, cardioverter, or defibrillator * any skin problem at the acupoint stimulation area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | within 24h after operation | the total number including nausea, retching and vomiting within 24h after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | within 24h after the operation | — |
| Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | within 24h after operation | including retching and vomiting |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need of Postoperative Metoclopramide | within 48h after operation | the number of patients who needed metoclopramide as a rescue medicine postoperatively |
Countries
China
Participant flow
Recruitment details
Patients were recruited from Jan 2014 to Dec 2014 in North Institute of Huashan Hospital,Fudan University,Shanghai,China
Pre-assignment details
243 patients were assessed for eligibility, 86 were excluded for reasons below: Refused to participate. (n=12) Did not meet inclusion criteria. (n=71) Insufficient time to prepare for the study. (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Acustimulation Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction | 50 |
| Tropisetron Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction | 53 |
| Control Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction | 50 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | converted to open procedures | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Acustimulation | Total | Control | Tropisetron |
|---|---|---|---|---|
| Age, Continuous | 37 years | 35 years | 35 years | 35 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 153 Participants | 50 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 50 participants | 153 participants | 50 participants | 53 participants |
| Sex: Female, Male Female | 50 Participants | 153 Participants | 50 Participants | 53 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 53 | 0 / 53 | 0 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 | 0 / 51 |
Outcome results
Primary
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
the total number including nausea, retching and vomiting within 24h after operation
Time frame: within 24h after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acustimulation | Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | 14 participants |
| Tropisetron | Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | 14 participants |
| Control | Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | 25 participants |
p-value: 0.021Chi-squared
Secondary
Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Time frame: within 24h after the operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acustimulation | Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | 14 participants |
| Tropisetron | Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | 14 participants |
| Control | Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | 25 participants |
p-value: 0.021Chi-squared
Secondary
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
including retching and vomiting
Time frame: within 24h after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acustimulation | Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | 9 participants |
| Tropisetron | Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | 8 participants |
| Control | Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | 12 participants |
p-value: 0.503Chi-squared
Other Pre-specified
Need of Postoperative Metoclopramide
the number of patients who needed metoclopramide as a rescue medicine postoperatively
Time frame: within 48h after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acustimulation | Need of Postoperative Metoclopramide | 5 participants |
| Tropisetron | Need of Postoperative Metoclopramide | 4 participants |
| Control | Need of Postoperative Metoclopramide | 7 participants |
p-value: 0.571Chi-squared