Back to resultsComparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery (P6 and PONV)
Primary Purpose
Mammary Cancer, PONV
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electric stimulation therapy
Sponsored by
About this trial
This is an interventional prevention trial for Mammary Cancer focused on measuring Mammary Cancer, PONV, electric stimulation therapy, antiemetics
Eligibility Criteria
Inclusion Criteria:
- women undergoing breast cancer resection under general anesthesia
- aged between 18 to 65
- American Society of Anesthesiologists grade I-II
Exclusion Criteria:
- using antiemetic drugs within 24 h before operation,
- nausea or vomiting within 24 h before operation;
- Alcoholic or drug abuse,
- abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
- refuse to participate clinical trial
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Sham Comparator
Arm Label
Group Acu
Group Gra
Group Dxm
Arm Description
a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation. At the start of skin closure, saline (3 ml) was administered i.v.
Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.
Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, saline (3 ml) was administered i.v.
Outcomes
Primary Outcome Measures
PONV within the first 24h after surgery
the incidence and severity of PONV
Secondary Outcome Measures
PONV within the first 48h after surgery
the incidence and severity of PONV
the use of postoperative antiemetics
the frequency and dose of postoperative antiemetics
postoperative pain score
Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05408676
Brief Title
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
Acronym
P6 and PONV
Official Title
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.
Detailed Description
186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammary Cancer, PONV
Keywords
Mammary Cancer, PONV, electric stimulation therapy, antiemetics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Acu
Arm Type
Experimental
Arm Description
a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation.
At the start of skin closure, saline (3 ml) was administered i.v.
Arm Title
Group Gra
Arm Type
Sham Comparator
Arm Description
Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.
Arm Title
Group Dxm
Arm Type
Sham Comparator
Arm Description
Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, saline (3 ml) was administered i.v.
Intervention Type
Device
Intervention Name(s)
electric stimulation therapy
Intervention Description
Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)
Primary Outcome Measure Information:
Title
PONV within the first 24h after surgery
Description
the incidence and severity of PONV
Time Frame
24 hours after surgery.
Secondary Outcome Measure Information:
Title
PONV within the first 48h after surgery
Description
the incidence and severity of PONV
Time Frame
48 hours after surgery
Title
the use of postoperative antiemetics
Description
the frequency and dose of postoperative antiemetics
Time Frame
48 hours after surgery
Title
postoperative pain score
Description
Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women undergoing breast cancer resection under general anesthesia
aged between 18 to 65
American Society of Anesthesiologists grade I-II
Exclusion Criteria:
using antiemetic drugs within 24 h before operation,
nausea or vomiting within 24 h before operation;
Alcoholic or drug abuse,
abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
refuse to participate clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
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