Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

NCT02066727 | Completed Results

• 1 other identifier: GW002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nerve Block

Keywords

Dexmedetomidine; obturator nerve block; lidocaine; EC50

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Complication Related With Nerve Block

  during operation, 0.5,24hour postoperatively

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.

Drug: Dexmedetomidine

Normal Saline

PLACEBO COMPARATOR

Normal Saline is administrated as an adjuvant of lidocaine.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.

Dexmedetomidine

Normal Saline DRUG

Normal Saline is administrated as an adjuvant of lidocaine.

Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
• Subject's American Society of Anesthesiologists physical status is I-II.
• The subject's parent/legally authorized guardian has given written informed consent to participate.

You may not qualify if:

• Subject has a diagnosis of abnormal coagulation function.
• Subject has a diagnosis of Diabetes mellitus.
• Subject has a preexisting neurologic deficits of the lower extremities.
• Subject has a history of alcohol or drug abuse.
• Subject is pregnant or breast-feeding.
• Subject is obese (body mass index \>30kg/m2).

Sponsors & Collaborators

• Guolin Wang: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

Tainjin Medical University General Hospita& the Second Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

• 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.

  PMID: 27341450 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Yuechun LU
• Organization: Tianjin Medical University General Hospital

luyuechun@sina.com

15902233666

Study Officials

• Guolin Wang, MD.PHD

  Tainjin Medical University General Hospita

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tianjin Medical University General Hospital

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

CN (1)