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Comparision between two different anaesthesia techniques - one opioid based and another opioid free in patients undergoing open abdominal surgery for gynaecological (female genital tract) cancer

Comparision between opioid based anaesthesia technique and opioid free anaesthesia technique in patients undergoing laparotomy for gynaecological malignancy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013335
Enrollment
50
Registered
2018-04-18
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- Gynaecological Malignancy Health Condition 2: C51-C58- Malignant neoplasms of female genital organs

Interventions

Intervention1: Dexmedetomidine, Ketamine (Opioid free group): In this group, anaesthesia induction will be performed with a Dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes (Infusion analgesic) alo

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-II scheduled to undergo Elective open gynaecological oncology surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1)Patients refusal 2)ASA III OR IV 3)Allergy to any of the study drugs 4)Contraindications to regional technique e.g., allergy to local anaesthetic drugs, infection around site of block ,any coagulation disorder, sepsis 5)History of analgesic dependence (long term use) and opiate tolerance 6)Pre-existing chronic pain with regular use of medications 7)Epilepsy and psychiatric disturbances

Design outcomes

Primary

MeasureTime frame
Time to attain the PACU discharge criteriaTimepoint: post operative period 2 hours

Secondary

MeasureTime frame
Opioid induced hyperalgesia (OIH)Timepoint: at PACU discharge and at 24 hours;Post-operative analgesic consumptionTimepoint: for 24 hours;Post-operative nausea and vomiting(PONV)Timepoint: till 24 hours;Quality of recovery as measured by QoR- 15 questionnaireTimepoint: at 12 and 24 hours;Time to extubationTimepoint: time from switching off inhalational agent to extubation;Time to first analgesic in PACUTimepoint: post operative period 2 hours;Time to shiftingTimepoint: time from switching off inhalational agent to shifting the patient out of theatre;VAS scoreTimepoint: on arrival in PACU

Countries

India

Contacts

Public ContactKALAGARA RESHMA

All India Institute of Medical Sciences, New Delhi

debeshbhoi@gmail.com7042129428

Outcome results

None listed

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