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Pressure


- candidate number27232
- NTR NumberNTR6422
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2017
- Secondary IDs17-N-74 METC Zuyderland Heerlen
- Public TitlePressure
- Scientific TitlePressure pneumoperitoneum And Relaxing agents to create Safety in laparoscopic Surgery and Reduce post operative painlevels”
- ACRONYMPRESSURE
- hypothesisWith help of the TOF watch, a reduction in muscle relaxation can be observed earlier. In this way, peroperative events (pain or contractions by the patient) can be prevented. Less peroperative events lead to less postoperative pain.
- Healt Condition(s) or Problem(s) studiedEndometriosis, Laparoscopy, Myoma, Blood loss
- Inclusion criteria- Female, 18yr and older
- benign gynaecological laparoscopies and early staged malignancies
o Hysterectomy, o Cystectomy o Adnexextirpation o Tubectomy o Adhesiolysis o Endometriosis removal o Myomectomy o sterilisation o Essure verwijdering o Figo 1-2 (t/m stadium 2) endometrium carcinoom -

Kan informed consent lezen en ondertekenen
- Exclusion criteriamalignant diseas with metastasis
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-mei-2017
- planned closingdate31-aug-2017
- Target number of participants20
- InterventionsTOF WATCH: this device will be placed at the hand of the patient. TOF scores are blinded from the surgeon and anesthesist. The rest of the surgery will be just as normal.
- Primary outcomeTOF-scores (compared to peroperative events >> when the patient reacts) and Postoperative painlevels (shoulder, abdominal, other)
- Secondary outcomenausea and vomiting
lengt of hospital stay
operation duration
- Timepoints- Degree of muscle relaxation measured during surgery using the TOF watch.
- Postoperative pain measured during one week after surgery: 1hour and 3 hours post operatively, 3 times a day at day 1-3 and 1 time a day at day 4-7.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Nadine Weijermans
- CONTACT for SCIENTIFIC QUERIES Nadine Weijermans
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland Medical Center, Heerlen
- Publications
- Brief summaryThis study is a baseline measurement at gynaecologic laparoscopic surgeries. We want to know if gynaecologists and anaesthesiologists work according a specific protocols about intraperitoneal pressure levels, the level of neuromuscular blockade and painmedication.

During surgery a TOF-watch is attached to the patient. The investigator fills out a self-developed data collection form: Items on this form are: Duration of surgery, medication (sleep- and pain medication, muscle relaxants), positioning of the patient, the intraperitoneal pressures, events dat occur durig surgery, Actions of the anaesthesiology nurse, TOF values.

After surgery patients receive a questionnaire were they have to fill out there postoperative pain levels: shoulder pain, abdominal pain and incisional pain. Further they have to fill out if they took pain medication, if they was any nausea or vomiting and if they took medication to prevent that. Measure moments are: 1hour and 3 hours post operatively, 3 times a day at day 1-3 and 1 time a day at day 4-7.
- Main changes (audit trail)
- RECORD17-mei-2017 - 26-jun-2017


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