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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor
A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
|
| Normal Saline | Placebo Comparator | Normal Saline is administrated as an adjuvant of lidocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Effective Concentration(EC50) | Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration. For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows. | 10min |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Related With Nerve Block | Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively | during operation, 0.5,24hour postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guolin Wang, MD.PHD | Tainjin Medical University General Hospita | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tainjin Medical University General Hospita& the Second Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27341450 | Derived | Lu Y, Sun J, Zhuang X, Lv G, Li Y, Wang H, Wang G. Perineural Dexmedetomidine as an Adjuvant Reduces the Median Effective Concentration of Lidocaine for Obturator Nerve Blocking: A Double-Blinded Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158226. doi: 10.1371/journal.pone.0158226. eCollection 2016. |
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The patients with the following condition was excluded from the study: ASA III orIV; weight <50 or >100 kg；BMI<19 or >30kg/m2；age younger than 18 yr or older than 80yr；preexisting neurologic deficits of the lower extremities, DM; alcohol or drug abuse; abnormal coagulation function
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Normal Saline is administrated as an adjuvant of lidocaine. |
| FG001 | Dexmedetomidine | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Normal Saline is administrated as an adjuvant of lidocaine. |
| BG001 | Dexmedetomidine | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Median Effective Concentration(EC50) | Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration. For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows. | Posted | Number | 95% Confidence Interval | mg/ml(the concentration of lidocaine) | 10min |
|
Form the completion of obturator nerve block to 24 hours after operation.
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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 | Normal Saline | Normal Saline is administrated as an adjuvant of lidocaine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yuechun LU | Tianjin Medical University General Hospital | 15902233666 | luyuechun@sina.com |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal Saline | Drug | Normal Saline is administrated as an adjuvant of lidocaine. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Normal Saline is administrated as an adjuvant of lidocaine. Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine. |
| OG001 | Dexmedetomidine | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
|
|
| Secondary | Complication Related With Nerve Block | Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively | Not Posted | during operation, 0.5,24hour postoperatively |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Dexmedetomidine | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. | 0 | 30 | 0 | 30 |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |