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Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C group, (n=20) | Placebo Comparator | C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. |
|
| TDN group, (n=20) | Active Comparator | TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. |
|
| TDM group, (n=20) | Active Comparator | TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| A Mean Difference of Total Analgesic (Pethidine) Consumption. | [Time Frame: The total pethidine requirements (mg) 12 hours postop] |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | C Group, (n=20) | C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| FG001 | TDN Group, (n=20) | TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| FG002 | TDM Group, (n=20) | TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C Group, (n=20) | C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Mean Difference of Total Analgesic (Pethidine) Consumption. | Posted | Mean | Standard Deviation | mg | [Time Frame: The total pethidine requirements (mg) 12 hours postop] |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C Group, (n=20) | C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. Placebo: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ibrahim Mamdouh Esmat | Ain-Shams University Hospitals | 01001241928 | ibrahim_mamdouh@med.asu.edu.eg |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| transdermal therapeutic system- nicotine. | Drug | Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
|
|
| transdermal therapeutic system- melatonin. | Drug | Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
|
|
| BG001 | TDN Group, (n=20) | TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| BG002 | TDM Group, (n=20) | TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of anesthesia (min) | Mean | Standard Deviation | minutes |
|
| OG002 | TDM Group, (n=20) | TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | TDN Group, (n=20) | TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- nicotine.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. | 4 | 20 | 8 | 20 |
| EG002 | TDM Group, (n=20) | TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. transdermal therapeutic system- melatonin.: Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. | 0 | 20 | 0 | 20 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|