Patients have a better recovery after laparoscopic sterilization under conscious sedation compared to general anesthesia as measured with the QoR-40 one day after surgery.
ID
Bron
Aandoening
laparoscopy, sterilization, sedation, general anesthesia.
Laparoscopie, sterilisatie, sedatie, algehele anesthesie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total patients’ recovery as measured with the Quality of Recovery 40 questionnaire (QoR-40) one day after surgery
Achtergrond van het onderzoek
Female sterilization is the most popular and common contraceptive method worldwide.A recently published systematic review shows that patients might benefit from a laparoscopic sterilization
procedure using conscious sedation compared to general anesthesia. However, only few and relatively old studies could be included, pointing out the importance of new research regarding this subject.Therefore, we will perform a randomized controlled trial to study the difference in patients' recovery when using conscious sedation instead of general anesthesia for laparoscopic sterilization.
Doel van het onderzoek
Patients have a better recovery after laparoscopic sterilization under conscious sedation compared to general anesthesia as measured with the QoR-40 one day after surgery.
Onderzoeksopzet
1. Admission, surgery and recovery time and peri-operative parameters during admission
2. Patients' recovery 1 day after surgery
3. Patients' recovery 1 week after surgery
4. Complications until 6 weeks after surgery
Onderzoeksproduct en/of interventie
Conscious sedation versus general anesthesia
Publiek
Dana Huppelschoten
Jeroen Bosch Hospital
Den Bosch
The Netherlands
0615339787
dana.huppelschoten@catharinaziekenhuis.nl
Wetenschappelijk
Dana Huppelschoten
Jeroen Bosch Hospital
Den Bosch
The Netherlands
0615339787
dana.huppelschoten@catharinaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years or older
- Classificantion: ASA 1 or 2
- Being able to understand the Dutch language
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Younger than 18 years
- no Dutch speaking
- Extensive abdominal surgery in the past which high chance of adhesions
- Classification ASA 3 of 4
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5526 |
| NTR-old | NTR7092 |
| Ander register | MEC-U : R19.006 |