Exploration of the effectiveness and potential value of dexmedetomidine-oriented opioid free anesthesia (OFA) regimen in elective major abdominal surgery: a randomized controlled trial.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061134

Enrollment

Unknown

Registered

2022-06-15

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-03-26

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

Conditions

Patients undergoing major abdominal surgery

Interventions

Group RM:No use of DEX neither intravenously nor via epidural catheter. Intravenous use of remifentanil. Epidural use of ropivacaine and morphine for analgesia perioperatively.

Group RD:No use of DEX intravenously. Intravenous use of remifentanil. Epidural use of ropivacaine and DEX for analgesia perioperatively.

Group D:DEX-oriented OFA regimen. Intravenous use of DEX before anesthesia induction and during maintenance. Epidural use of ropivacaine and DEX for analgesia perioperatively.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70; 2. ASA grade I-II; 3. Patients undergoing elective major abdominal surgery; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Known allergy or intolerance to dexmedetomidine (DEX), morphine or ropivacaine; 2. Preoperative ECG confirmed sinus bradycardia or any conduction blocks; 3. In use of a-receptor antagonist; 4. Long term use of any opioid for chronic pain relief; 5. Refuse to participate in this study; 6. Participate in other clinical trials within 30 days before randomization; 7. With severe cardiovascular disease, liver dysfunction or renal dysfunction; 8. With contraindications or relative contraindications to epidural puncture, including but not limited to coagulation dysfunction, insufficient withdrawal time of anticoagulant drugs, elevated intracranial pressure, back injury with previous neurological impairment, progressive neurological disorders (e.g. multiple sclerosis), chronic back pain, local infection of puncture site; 9. Cannot cooperate with epidural puncture.

Design outcomes

Primary

Measure	Time frame
visual analogue score (measured during rest and movement) ;analgesic satisfaction level;cumulative PCEA consumption;PCEA bolus;rescue analgesic medication ;	—

Secondary

Measure	Time frame
incidence of hypotension;incidence of bradycardia ;incidence of nausea and vomiting ;incidence of itching;incidence of shivering;incidence of excessive sedation;incidence of respiratory depression;incidence of dizziness;incidence of delirium;sedative level (MOAA/S score);	—

Countries

China

Contacts

Public ContactSiyang Wang

Zhongshan Hospital, Fudan University

wangsiyang2010@foxmail.com+86 15221318131

Outcome results

None listed

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