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Study Comparing the recovery after general anaesthesia between fentanyl and pentazocine

A Randomised Prospective double blinded Observational study to Compare the Post General Anaesthesia recovery with Pentazocine and Fentanyl groups along with other preanaesthetic medications in a tertiary care hospital at Puducherry - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092586
Enrollment
104
Registered
2025-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: Nil: Nil Intervention2: Fentanyl: Inj. FENTANYL 2mcg/kg i.v stat. only one dose before surgery Control Intervention1: Pentazocine: Inj. PENTAZOCINE 0.6mg/kg i.v stat, only one dose befo

Sponsors

Dr.Snegaamarane K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18-60yrs. 2. Patients of both gender. 3. Patients with BMI 18.5 -22.9 (acc. to WHO Asian BMI scale ) 4. Patients with controlled hypertension. 5. Patients with controlled Diabetes mellitus. 6. Patients with controlled hypothyroid. 7. Patients who are given Opioid free analgesia except induction. 8. Patients undergoing surgeries under plain General Anaesthesia with duration of 2-3hrs (like breast surgeries, CSOM (Chronic suppurative Otitis Media) surgeries, spine and other minor orthopedic surgeries, Total Abdominal Hysterectomy with Bilateral Salphingo-Oophorectomy, Appendicectomy, Herniorrhaphy, lymph node excision on neck.,) 9. Patients who had smooth extubation process.

Exclusion criteria

Exclusion criteria: 1. Patients with following comorbidities (Acid Peptic Disease, Asthma, Pulmonary edema, Pulmonary fibrosis, Coronary artery disease) 2. Patients with difficulty airway. 3. Patients with known psychiatric illness. 4. Patients undergoing surgery with Duration of more than 3hrs. 5. Patients undergoing Laparoscopic surgery, adenotonsillectomy and other oral surgery. 6. Patients who are developing intraoperative events such as somatic arousal, pain perception, tachy/bradycardia.

Design outcomes

Primary

MeasureTime frame
To compare the incidence of postoperative pain, nausea/vomiting and sore throat between fentanyl and pentazocine groupsTimepoint: Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward.

Secondary

MeasureTime frame
To compare the incidence of Delirium, Respiratory depression,hoarseness of voice, cough between pentazocine and fentanyl groups.Timepoint: Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward.

Countries

India

Contacts

Public ContactDrMSakthi Balan

Sri Venkateshwaraa Medical College Hospital and Research Centre

saheerose@gmail.com9443627722

Outcome results

None listed

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