Trial Outcomes & Findings for Acupuncture for Reduction of Inflammation (NCT NCT01937520)
NCT ID: NCT01937520
Last Updated: 2017-04-13
Results Overview
analgesia provided in Post Anesthesia Care Unit PACU)
COMPLETED
NA
20 participants
amount of pain medication provided in PACU
2017-04-13
Participant Flow
Participants were recruited in a Same Day Surgery Suite at a academic medical center. The first participant was enrolled on 7/2/13 and last patient enrolled on 7/15/14.
Participant milestones
| Measure |
Acupuncture
acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham
no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group
no acupuncture: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Reduction of Inflammation
Baseline characteristics by cohort
| Measure |
Acupuncture
n=11 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group
no acupuncture: placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Customized
45 years or older
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: amount of pain medication provided in PACUPopulation: All subjects enrolled in study
analgesia provided in Post Anesthesia Care Unit PACU)
Outcome measures
| Measure |
Acupuncture
n=11 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Reduced Pain Medication Requirement
|
5.43 mg of Morphine
Standard Error 1.70
|
7.36 mg of Morphine
Standard Error 1.49
|
PRIMARY outcome
Timeframe: arrival in PACU to 2 hours post operativelyPopulation: all study participants
VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average
Outcome measures
| Measure |
Acupuncture
n=11 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Visual Acuity Score (VAS)
|
5.36 units on a scale
Standard Error 0.97
|
6.67 units on a scale
Standard Error 1.01
|
PRIMARY outcome
Timeframe: PACU, day 1 , day 2, day 3Population: since gender impacts the threshold for analgesic and pain the effects of electroacupuncture on females was analyzed. The same number of females were in both groups but since one subject had preexisting levels of TNF\>1ug/ml prior to surgery she was eliminated from the dta base
equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Morphine Equivalent
PACU
|
3.19 mg morphine
Standard Error 1.59
|
7.36 mg morphine
Standard Error 1.49
|
|
Morphine Equivalent
Day 1
|
6.31 mg morphine
Standard Error 2.14
|
9 mg morphine
Standard Error 2.44
|
|
Morphine Equivalent
Day 2
|
9.84 mg morphine
Standard Error 3.44
|
7.42 mg morphine
Standard Error 2.37
|
|
Morphine Equivalent
Day 3
|
7.93 mg morphine
Standard Error 3.35
|
5.25 mg morphine
Standard Error 2.32
|
PRIMARY outcome
Timeframe: PACU, day 1 , day 2, day 3Population: female patients self reported pain experience following surgery
Visual Acuity scale 0=no pain 10= worst pain possible
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Pain Levels
PACU
|
4.88 units on a scale
Standard Error 1.29
|
6.67 units on a scale
Standard Error 1.01
|
|
Pain Levels
Day 1
|
6.67 units on a scale
Standard Error 1.09
|
5.56 units on a scale
Standard Error 0.96
|
|
Pain Levels
day2
|
5 units on a scale
Standard Error 1.09
|
5.93 units on a scale
Standard Error 0.49
|
|
Pain Levels
day3
|
4.28 units on a scale
Standard Error 0.95
|
3.33 units on a scale
Standard Error 0.96
|
SECONDARY outcome
Timeframe: serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACUPopulation: females
All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
(ACTH )Adrenocorticotropic Hormone
preoperative
|
8.56 pg/ml
Standard Error 2.60
|
21.32 pg/ml
Standard Error 7.08
|
|
(ACTH )Adrenocorticotropic Hormone
intraoperative
|
15.26 pg/ml
Standard Error 12.13
|
21.41 pg/ml
Standard Error 8.30
|
|
(ACTH )Adrenocorticotropic Hormone
postoperative
|
53.36 pg/ml
Standard Error 33.84
|
202 pg/ml
Standard Error 74.37
|
|
(ACTH )Adrenocorticotropic Hormone
post op<45years
|
110 pg/ml
Standard Error 88.94
|
276.1 pg/ml
Standard Error 221.9
|
|
(ACTH )Adrenocorticotropic Hormone
postop>45 years
|
19.4 pg/ml
Standard Error 8.09
|
177.3 pg/ml
Standard Error 80.96
|
|
(ACTH )Adrenocorticotropic Hormone
postop<75kg
|
15.03 pg/ml
Standard Error 5.85
|
27.85 pg/ml
Standard Error 14.35
|
|
(ACTH )Adrenocorticotropic Hormone
postop>75 kg
|
83.48 pg/ml
Standard Error 68.23
|
376.2 pg/ml
Standard Error 73.39
|
SECONDARY outcome
Timeframe: PACU to 2 hours post opPopulation: females grouped by age (\<45 years and 45 years or greater)
All analgesic treatments were converted to morphine equivalents in milligrams .
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Morphine Equivalent
< 45 years old
|
2 mg of Morphine
Standard Error 1.16
|
9.75 mg of Morphine
Standard Error 2.75
|
|
Morphine Equivalent
> 45 years old
|
3.9 mg of Morphine
Standard Error 2.52
|
6.68 mg of Morphine
Standard Error 1.76
|
SECONDARY outcome
Timeframe: PACU arrival to 2 hours post opPopulation: females with body weight \<75 kg and \>than 75 kg
morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Morphine Equivalent (mg)
<75 kg
|
3.25 mg morphine
Standard Error 2.38
|
9.69 mg morphine
Standard Error 1.48
|
|
Morphine Equivalent (mg)
>75 kg
|
4.63 mg morphine
Standard Error 2.63
|
5.5 mg morphine
Standard Error 2.17
|
SECONDARY outcome
Timeframe: Day 1, 2, 3Population: all females
Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Modified Quality of Recovery Scale
Day 1
|
14.5 units on a scale
Standard Error 0.98
|
13.33 units on a scale
Standard Error 0.85
|
|
Modified Quality of Recovery Scale
Day 2
|
16 units on a scale
Standard Error 0.73
|
15.89 units on a scale
Standard Error 0.75
|
|
Modified Quality of Recovery Scale
Day 3
|
17.57 units on a scale
Standard Error 0.3
|
17 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: prior to surgical incision, 1 hour following incision, after arrival in PACUPopulation: females
All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Cortisol
postoperative
|
267.4 ng/ml
Standard Error 89.33
|
394.4 ng/ml
Standard Error 104.6
|
|
Cortisol
preoperative
|
173.6 ng/ml
Standard Error 83.3
|
155.2 ng/ml
Standard Error 40.37
|
|
Cortisol
intraoperative
|
103.1 ng/ml
Standard Error 19.93
|
145.2 ng/ml
Standard Error 26.85
|
|
Cortisol
postoperative<45 years
|
375.6 ng/ml
Standard Error 229.1
|
480 ng/ml
Standard Error 302.1
|
|
Cortisol
postoperative>45 years
|
202.4 ng/ml
Standard Error 61.55
|
365.8 ng/ml
Standard Error 116.9
|
|
Cortisol
postoperative<75 kg
|
252.1 ng/ml
Standard Error 88.76
|
170.7 ng/ml
Standard Error 67.28
|
|
Cortisol
postoperative>75 kg
|
296 ng/ml
Standard Error 180.5
|
618.1 ng/ml
Standard Error 114.6
|
SECONDARY outcome
Timeframe: serum glucose from baseline to PACU arrivalPopulation: females
the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Glucose
preoperative
|
150.4 mg/dL
Standard Error 11.36
|
164.4 mg/dL
Standard Error 10.94
|
|
Glucose
intraoperative
|
154.3 mg/dL
Standard Error 8.75
|
187.1 mg/dL
Standard Error 15.82
|
|
Glucose
postoperative
|
152.8 mg/dL
Standard Error 7.76
|
208.1 mg/dL
Standard Error 13.36
|
|
Glucose
post op < 45 years
|
154.7 mg/dL
Standard Error 9.39
|
190 mg/dL
Standard Error 26
|
|
Glucose
post op > 45 years
|
151.6 mg/dL
Standard Error 11.88
|
213.3 mg/dL
Standard Error 15.93
|
|
Glucose
postop <75 kg
|
144.3 mg/dL
Standard Error 7.22
|
210.3 mg/dL
Standard Error 32.46
|
|
Glucose
post op >75 kg
|
148.5 mg/dL
Standard Error 9.06
|
206.4 mg/dL
Standard Error 2.98
|
SECONDARY outcome
Timeframe: preoperatively-intraoperatively-postoperativelyPopulation: female subjects
First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Tumor Necrosis Factor (TNF)
postoperative
|
1.98 pg/ml
Standard Error 1.0
|
1.9 pg/ml
Standard Error 0.7
|
|
Tumor Necrosis Factor (TNF)
preoperatively
|
1.88 pg/ml
Standard Error 0.67
|
2.14 pg/ml
Standard Error 0.63
|
|
Tumor Necrosis Factor (TNF)
intraoperative
|
2.09 pg/ml
Standard Error 0.62
|
2.25 pg/ml
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Preoperatively-intraoperatively-postoperativelyPopulation: all females
both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-2 postoperative
|
2.33 pg/ml
Standard Error 1.31
|
2.77 pg/ml
Standard Error 2.24
|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-2preoperative
|
2.64 pg/ml
Standard Error 1.53
|
4.26 pg/ml
Standard Error 3.62
|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-2intraoperative
|
2.38 pg/ml
Standard Error 1.3
|
3.4 pg/ml
Standard Error 2.87
|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-4 preoperative
|
0.52 pg/ml
Standard Error 0.15
|
0.59 pg/ml
Standard Error 0.25
|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-4 intraoperative
|
0.57 pg/ml
Standard Error 0.27
|
0.56 pg/ml
Standard Error 0.28
|
|
iNTERLEUKIN (IL-2 and IL-4)
IL-4 postoperative
|
0.41 pg/ml
Standard Error 0.12
|
0.37 pg/ml
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Preoperatively-intraoperatively-postoperativelyPopulation: total female results; then females divided into age groups (\<45 or \>45years) and weights groups (\<75kg and \>75kg)
First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
IL-6
IL-6 preoperatively
|
3.58 pg/ml
Standard Error 0.92
|
4.65 pg/ml
Standard Error 0.34
|
|
IL-6
IL-6 intraoperatively
|
4.98 pg/ml
Standard Error 1.1
|
4.66 pg/ml
Standard Error 0.4
|
|
IL-6
IL-6 postoperatively
|
26.96 pg/ml
Standard Error 10.35
|
27.45 pg/ml
Standard Error 7.85
|
|
IL-6
IL-6 <45 yrs post op
|
23.10 pg/ml
Standard Error 5.3
|
30.9 pg/ml
Standard Error 6.9
|
|
IL-6
IL-6 >45 yrs postop
|
29.28 pg/ml
Standard Error 16.97
|
26.46 pg/ml
Standard Error 10.14
|
|
IL-6
IL-6 <75 kg postop
|
37.15 pg/ml
Standard Error 28.41
|
16 pg/ml
Standard Error 3.4
|
|
IL-6
IL-6 >75 kg postop
|
25.44 pg/ml
Standard Error 4.47
|
36.61 pg/ml
Standard Error 12.95
|
SECONDARY outcome
Timeframe: Preoperatively-intraoperatively-postoperativelyPopulation: total females; then those grouped by age (\<45years and\>45 years) and weight (\<75 Kg and \>75kg)
IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
IL-10
IL_10 intraoperative
|
7.28 pg/ml
Standard Error 1.62
|
7.81 pg/ml
Standard Error 2.22
|
|
IL-10
IL-10 postoperative
|
16.15 pg/ml
Standard Error 9.4
|
16.14 pg/ml
Standard Error 4.07
|
|
IL-10
IL-10 preoperatively
|
5.35 pg/ml
Standard Error 0.93
|
6.0 pg/ml
Standard Error 0.8
|
|
IL-10
IL-10 <45 yrs postop
|
40.23 pg/ml
Standard Error 13.64
|
13.64 pg/ml
Standard Error 10.07
|
|
IL-10
IL-10 >45 postop
|
7.7 pg/ml
Standard Error 1.19
|
16.86 pg/ml
Standard Error 4.8
|
|
IL-10
IL-10 <75kg postop
|
8.6 pg/ml
Standard Error 1.6
|
10.7 pg/ml
Standard Error 4.46
|
|
IL-10
IL-10>75kg postop
|
32.18 pg/ml
Standard Error 26.58
|
20.47 pg/ml
Standard Error 6.1
|
SECONDARY outcome
Timeframe: Preoperatively-intraoperatively-postoperativelyPopulation: all females; then females by groups age (\<45 years and \>45 years) and weight (\<75kg and \>75kg)
TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
TGFB1
>45 yrs postop
|
46.2 pg/ml
Standard Error 9.9
|
15.2 pg/ml
Standard Error 2.8
|
|
TGFB1
<75 kg postop
|
56.76 pg/ml
Standard Error 13.51
|
13.96 pg/ml
Standard Error 5.39
|
|
TGFB1
intraoperative
|
19.5 pg/ml
Standard Error 6.28
|
9.4 pg/ml
Standard Error 3.5
|
|
TGFB1
postoperative
|
35.17 pg/ml
Standard Error 8.8
|
12.9 pg/ml
Standard Error 2.65
|
|
TGFB1
preoperative
|
7.30 pg/ml
Standard Error 3.5
|
3.26 pg/ml
Standard Error 1.53
|
|
TGFB1
<45 yrs post op
|
16.76 pg/ml
Standard Error 11.37
|
4.89 pg/ml
Standard Error 0.48
|
|
TGFB1
>75kg postop
|
21.3 pg/ml
Standard Error 9.2
|
12.11 pg/ml
Standard Error 2.73
|
SECONDARY outcome
Timeframe: preoperative and postoperativePopulation: female subjects preoperatively and postoperatively
to determine if electroacupuncture reduced hyperglycemia
Outcome measures
| Measure |
Acupuncture
n=8 Participants
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment
|
Sham/Placebo
n=9 Participants
no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo
|
|---|---|---|
|
Serum Insulin Level
preoperative
|
257.4 pg/ml
Standard Error 92.8
|
378.1 pg/ml
Standard Error 95.05
|
|
Serum Insulin Level
postoperative
|
311.2 pg/ml
Standard Error 50.59
|
325.4 pg/ml
Standard Error 84.46
|
Adverse Events
Acupuncture
Sham/Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dennis Grech, MD
Rutgers, The State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place