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NCT04196946
Use of Intrathecal Analgesia in Appendectomy
NA trial testing 25 mcg fentanyl in Anesthesia in 50 participants. Completed in 2 September 2019.
2 September 2015
Quick facts
| Lead sponsor | Nigde Omer Halisdemir University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 2 September 2013 |
| Primary completion | 2 September 2015 |
| Estimated completion | 2 September 2019 |
Drugs / interventions tested
- 25 mcg fentanyl — full drug profile →
- 250 mcg alfentanil — full drug profile →
Conditions studied
- Anesthesia — all drugs for Anesthesia →
- Analgesia — all drugs for Analgesia →
Sponsor
Nigde Omer Halisdemir University
Who can join
Adults 20 to 60, any sex, with Anesthesia or Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute appendicitis which is the most common cause of acute abdominal pain, is an acute inflammation of appendix vermiformis. Appendectomy operations can be performed as laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to improve the quality of preoperative analgesia is an increasingly used method in recent years. The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are used intrathecally to create motor and sensory block. 50 volunteer patients who were diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general surgery clinic and classified as American Society of Anesthesiologists Classification I-II (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation, were included in this study. The patients were randomly assigned into two groups, Group I and Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25 mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg alfentanil (0.5 cc) intrathecally (Group II, n=25).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04196946
- Europe PMC full search
- ASCO Meeting Library
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Other Nigde Omer Halisdemir University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04196946 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nigde Omer Halisdemir University
- Last refreshed: 12 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04196946.
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