No registrations found.
ID
Source
Health condition
laparoscopy, sterilization, sedation, general anesthesia.
Laparoscopie, sterilisatie, sedatie, algehele anesthesie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total patients’ recovery as measured with the Quality of Recovery 40 questionnaire (QoR-40) one day after surgery
Secondary outcome
Number of complications, operating times, recovery times, peri-operative parameters such as heart rate, blood pressure and saturation, and late patients’ recovery as measured with the Recovery Index-10 (RI-10)
Background summary
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.
Study objective
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.
Study design
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
Intervention
Conscious sedation versus general anesthesia
Dana Huppelschoten
Jeroen Bosch Hospital
Den Bosch
The Netherlands
0615339787
dana.huppelschoten@catharinaziekenhuis.nl
Dana Huppelschoten
Jeroen Bosch Hospital
Den Bosch
The Netherlands
0615339787
dana.huppelschoten@catharinaziekenhuis.nl
Inclusion criteria
- 18 years or older
- Classificantion: ASA 1 or 2
- Being able to understand the Dutch language
Exclusion criteria
- Younger than 18 years
- no Dutch speaking
- Extensive abdominal surgery in the past which high chance of adhesions
- Classification ASA 3 of 4
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5526 |
| NTR-old | NTR7092 |
| Other | MEC-U : R19.006 |