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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03565705
Other study ID # 042017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 24, 2018
Est. completion date October 14, 2018

Study information

Verified date January 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.


Description:

Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.


Recruitment information / eligibility

Status Completed
Enrollment 636
Est. completion date October 14, 2018
Est. primary completion date August 8, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective, radical abdominal prostatectomy

- >18 years

Exclusion Criteria:

- chronic pain therapy (e.g. out-of-hospital opioid therapy)

- laparoscopic approach

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open abdominal prostatectomy
Patients undergo standardized open abdominal prostatectomy.

Locations

Country Name City State
Germany Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative opioid consumption Consumption of piritramid [mg] in PACU. 1 day
Secondary Intra-operative opioid consumption Consumption of sufentanil [mg] during surgery. Piritramid is given if NRS score is > 3. 1 day
Secondary Pain maximum Postoperative pain level measured with the highest score in numeric pain rating scale (NRS) 1 day
Secondary Postoperative recovery time Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward. 1 day
Secondary PONV/Shivering Occurence of post-operative nausea and vomiting or shivering in PACU. 1 day
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