Postoperative bowel dysfunction: effect of less opioid anesthesia and enhanced recovery after complex spine surgery: prospective randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20201229001

Enrollment

Unknown

Registered

2020-12-29

Start date

2021-11-17

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

elective complex spine surgery postoperative bowel dysfunction, postoperative ileus, Enhanced Recovery After Surgery, spine surgery, intraoperative opioid

Interventions

fentanyl 1&#45

2 mcg/kg then fentanyl 0.5&#45

1 mg/kg as need volatile anesthesia 0.5&#45

1.5 MAC,volatile anesthesia 0.5 MAC TCI propofol Cet 2&#45

6 mcg/ml lidocain 1.5&#45

2 mg/kg IV magnesium sulfate 40 mg/kg IV ketamine 0.3 .g/kg IV nefopam 20 mg IV then 60 mg in 24 hour postoperatively

Active Comparator Drug,Experimental Drug

opioid group,less opioid group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ASA class 1-3 Elective surgery thoracic or lumbar complex spine surgery (spinal instrument or more than 3 level )

Exclusion criteria

Exclusion criteria: patient refusal Cr > 2 mg/dL , eGFR < 50ml/min patient with caronary artery disease, congestive heart failure pateint with cerebrovascular disease, seizure BMI > 30 kg/m2. or body weight < 50 kg patient with spinal cord injury (complete cord lesion) patient with spinal tumor intraoperative neuromonitorings uncontrolled hypertension (BP > 180/110) constipation (defecation 2days/time) or use of laxatives patient with irritable bowel syndrome previous abdominal surgery patient recieved calcium channel blocker allergy to gabapentin, ketamine, magnesium, dexamethasone, lidocaine, dexamathesone, parecoxib, morphine,fentanyl disable to use intravenous patient controlled analgesia communication problem preoperative unstable hemodynamics

Design outcomes

Primary

Measure	Time frame
incidence of postopeartive bowel dysfunction 12 months first postoperative defecation before 48 hours	—

Secondary

Measure	Time frame
incidences of nausea vomiting, 12 months incidence,incidences of abdominal distention 12 months incidence,incidences of fart before 48 hours 12 months incidence,dietary habit 12 months subjective measurement	—

Countries

Thailand

Contacts

Public ContactThanitthi Thiparporn

siriraj hospital

thanitthi0111@gmail.com0815490323

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026