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Study on the effect of preoperative rectal administration of indomethacin combined with intraoperative magnesium sulfate intravenous drip on reducing postoperative cholestasis after cholangioscopy

Study on the effect of preoperative rectal administration of indomethacin combined with intraoperative magnesium sulfate intravenous drip on reducing postoperative cholestasis after cholangioscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071385
Enrollment
Unknown
Registered
2023-05-13
Start date
2023-05-08
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholelithiasis

Interventions

Group A (indomethacin+magnesium sulfate):30 minutes before surgery, a single rectal administration of 100mg of indomethacin suppository was given, and 10ml of magnesium sulfate was dissolved in 250ml
Group B (glycerol suppositories+isotonic saline):30 minutes before surgery, glycerol suppositories were administered to the anus, and 250ml of isotonic saline was intravenously administered before int

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of common bile duct stones combined with gallbladder stones by color ultrasound, CT, or magnetic resonance cholangiopancreatography (MRCP); (2) Age 18-75 years old; (3) Preoperative diameter of common bile duct = 8 mm; (5) Diameter of common bile duct stones<10mm; (6)T-Bil<34 umol/L; (7)ALT<150 U/L; (8)N%<85%; (9) The patient and their family members are aware of the study and agree to participate.

Exclusion criteria

Exclusion criteria: (1) History of epigastrium surgery. (2) Mirizzi syndrome. (3) Concomitant acute severe cholangitis or pancreatitis. (4) Suspected malignant tumor patients. (5) Severe dysfunction of organs such as the heart, brain, liver, spleen, lungs, and kidneys. (6) Pregnancy. (7) Merge with other benign and malignant diseases of the gallbladder, biliary tract, and liver. (8) Those who meet the contraindications of indomethacin and magnesium sulfate.

Design outcomes

Primary

MeasureTime frame
glutamyl transferase, GGT;

Secondary

MeasureTime frame
N%;ALT;WBC;visual analogue scale, VAS;Remedial pain relief time;Postoperative complication rate;

Countries

China

Contacts

Public ContactHan Wei

Beijing Luhe Hospital, Capital Medical University

dr-han1972@mail.ccmu.edu.cn+86 185 0193 3816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026