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A clinical study to assess the physical, mental and emotional status of the patients without prolonged duration of starvation before major surgeries of the face.

Psychosocial evaluation of patients undergoing oral and maxillofacial surgery using ERAS-Maxfac protocol a randomized control trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086575
Enrollment
24
Registered
2025-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: M270- Developmental disorders of jaws

Interventions

Intervention1: Study group: ERAS -MaxFac Protocol: ERAS MaxFac Protocol. Complex carbohydrate drink 2 hours prior to surgery. Intraoperative 0.2% Ropivacaine. Lipus Regimen Followed Post operatively.

Sponsors

Jasnoor Singh Sidhu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 - 50 years. Patients reporting for management of trauma involving maxilla and mandible. Patients reporting for management of developmental deformities involving maxilla and mandible. Patients categorized under ASA I or II. Patients reporting with Mallampati Score of I/II.

Exclusion criteria

Exclusion criteria: Patients less than 18 years and greater than 50 years. Patients categorized under ASA status III and IV. Patients with uncontrolled systemic diseases or concomitant head injuries, long bone injury, C- spine injury. Patients presenting with psychiatric illness

Design outcomes

Primary

MeasureTime frame
1.Stress by a) Biochemical evaluation of Serum Cortisol b) By Zung Self-Rating Anxiety Scale (SAS). 2.Bone Healing by a) Biochemical evaluation of Serum Osteocalcin, b) By radiological evaluation of CT-Bone Mineral Density. 3.Quality of life by WHOQOL-BREF. 4.Muscle Mass by Ultrasound, thickness of masseter in mm. 5.Pain by Visual analogue scale(VAS). 6.Blood Glucose by Capillary blood glucose Timepoint: 1.a) Serum Cortisol:Pre-op, Post-op (10:00 am, daily 7 days) b) Zung SAS: Pre-op, Post-op daily 7 days (1st week), once weekly 7 weeks. 2.a) Serum Osteocalcin:Pre-op, Post-op (8th week).b) CT-BMD: Pre-op,Post-op (8th week). 3.WHOQOL-BREF:Pre-op, post-op daily 7 days (1st week), once weekly 7 weeks. 4.Masseter thickness (USG):Pre-op, Post-op (8th week). 5.VAS:Post-op daily 7 days, once weekly 7 weeks. 6.CBG:Pre-op (3 times 6hrly), post-op (2 days, 6hrly), Day 3 7 (once daily).

Secondary

MeasureTime frame
1. Inflammation by serum IL6 2. Surgical site infection by Southampton Wound Score. 3. Aspiration present or not at Intra-op during intubation/extubation. 4. Post operative nausea & vomiting by Apfel Risk Score 5. Functional recovery by mouth opening Timepoint: 1. IL-6: Pre-op, Post-op (Days 1, 3, 5). 2. Southampton Wound Score: Post-op daily 7 days, once weekly 7 weeks. 3. Aspiration: Intra-op (intubation/extubation), Post-op Day 1, 2. 4. Apfel Score (PONV): Post-op Day 0, 1, 2. 5. Mouth Opening: Pre-op, Post-op Weeks 1 6(once weekly).

Countries

India

Contacts

Public ContactDr Elavenil Panneerselvam

SRM Dental College, Ramapuram, Bharathi Salai, Chennai 600089, Tamil Nadu, India

elavenilomfs@gmail.com9841254653

Outcome results

None listed

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