STUDY TO COMPARE RECOVERY FROM ANAESTHESIA IN CASES OF SPINE SURGERIES.

A PROSPECTIVE RANDOMIZED OBSERVATIONAL PHASE IV STUDY TO COMPARE RECOVERY FROM ANAESTHESIA USING INTRA-VENOUS DEXMEDETOMIDINE AND DESFLURANE OR SEVOFLURANE IN CASES OF SPINAL SURGERIES.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/05/006939

Enrollment

100

Registered

2016-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- PATIENTS UNDERGOING SPINE SURGERY

Interventions

Control Intervention1: SEVOFLURANE AND DESFLURANE: INHALATIONAL ANAESTHETIC AGENTS

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: 1. Age between 18-65 years 2. ASA I-II 3. Expected surgical time more than 180 minutes 4. Patients posted for spine surgery

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: 1. Patients own refusal for participation in the study 2. ASA grade 3 and 4. 3. Age 65yrs. 4. Emergency cases 5. Patients with valvular heart disease, intracardiac shunts, hepatic or renal disease, severe pulmonary disease, chronic alcoholism, drug abuse 6. BMI > 35 7. Previous exposure of Dexmedetomidine 8. Patient on Beta-blockers 9. Pregnant and lactating mothers

Design outcomes

Primary

Measure	Time frame
PRIMARY OBJECTIVE: To compare recovery from anaesthesia using a constant intra-venous infusion of Injection Dexmedetomidine and desflurane or sevoflurane inhalation in cases of spine surgeries (lasting for more than 3 hours) in terms of following parameters: 1. Extubation Time (ET) 2. Fast Track Criteria (FTC) 3. Aldrete Criteria (AC) Timepoint: 1.EXTUBATION TIME AT THE END OF SURGERY (FROM SWTCHING OFF OF INHALATIONAL AGENT AND DEXMEDETOMIDINE INFUSION TILL EXTUBATION) 2. FAST TRACK CRITERIA- AFTER EXTUBATION TILL 40 MINUTES IN RECOVERY ROOM 3. ALDRETE CRITERIA- AFTER EXTUBATION TILL 40 MINUTES IN RECOVERY ROOM	—

Measure

Time frame

PRIMARY OBJECTIVE: To compare recovery from anaesthesia using a constant intra-venous infusion of Injection Dexmedetomidine and desflurane or sevoflurane inhalation in cases of spine surgeries (lasting for more than 3 hours) in terms of following parameters: 1. Extubation Time (ET) 2. Fast Track Criteria (FTC) 3. Aldrete Criteria (AC) Timepoint: 1.EXTUBATION TIME AT THE END OF SURGERY (FROM SWTCHING OFF OF INHALATIONAL AGENT AND DEXMEDETOMIDINE INFUSION TILL EXTUBATION) 2. FAST TRACK CRITERIA- AFTER EXTUBATION TILL 40 MINUTES IN RECOVERY ROOM 3. ALDRETE CRITERIA- AFTER EXTUBATION TILL 40 MINUTES IN RECOVERY ROOM

—

Secondary

Measure	Time frame
1.POST-OPERATIVE ANALGESIC AND ANTIEMETIC REQUIREMENT 2. MONITER REQUIREMENT INHALATIONAL ANAESTHETIC AGENTS IN TERMS OF DIAL SETTING TO MAINTAIN MAC VALUE 1 3. LOOK FOR COMPLICATIONSTimepoint: 1 FROM EXTUBATION TILL 40 MINUTES IN RECOVERY ROOM 2 AND 3 DURING INTRA-OPERATIVE PERIOD OF UP TO 8 HOURS	—

Countries

India

Contacts

Public ContactDR SUYOG SAMBHAJI BAGADE

SETH G S MEDICAL COLLEGE & K E M HOSPITAL PAREL MUMBAI

yogitapatil76@gmail.com9833935747

Outcome results

None listed

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