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出境医 / 临床实验 / The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
Study Description
Brief Summary:
Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.
| Condition or disease |
|---|
| Anxiety |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | December 1, 2019 |
| Estimated Study Completion Date : | December 1, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- State-Trait Anxiety Inventory questionnaire [ Time Frame: 20-30 minutes. ]State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.
Criteria
Inclusion Criteria:
- Patients aged between 18 and 55 years.
- ASA I-II
- BMI 18-25
Exclusion Criteria:
- Major surgery
Contacts and Locations
Locations
| Turkey | |
| Yadigar Yılmaz | Recruiting |
| Istanbul, Turkey, 34230 | |
| Contact: Yadigar Yılmaz 5053069924 dryadigaryilmaz@gmail.com | |
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||
| First Posted Date | May 22, 2019 | ||||
| Last Update Posted Date | September 25, 2019 | ||||
| Actual Study Start Date | May 1, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
State-Trait Anxiety Inventory questionnaire [ Time Frame: 20-30 minutes. ] State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia | ||||
| Official Title | The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia | ||||
| Brief Summary | Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia. | ||||
| Condition | Anxiety | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 1, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||
| Ages | 18 Years to 55 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | |||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958578 | ||||
| Other Study ID Numbers | OKMEYDANI EAH 48670771-514.10 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | ||||
| Study Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | ||||
| Verification Date | September 2019 | ||||
