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临床试验/CTRI/2026/04/107230
CTRI/2026/04/107230尚未招募Unknown

To compare the analgesic efficacy and positive psychedelic symptoms of different doses of ketamine in combination with dexmedetomidine in patients undergoing opioid-sparing Breast cancer Surgery (BCS)

Rajiv Gandhi Cancer Institute and Research Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年4月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
75
试验地点
1

研究概览

简要总结

Breast cancer surgery is commonly associated with significant perioperative pain and opioids have been the cornerstone of analgesia. however, adverse effects associated with opioids has encouraged the development of opioid sparing anaesthesia. ketamine is a potent analgesic and is associated with dose dependent psychedlic side effects such as hallucinations, agitation and altered perception which limits its use in perioperative analgesia. dexmedetomidine has been shown to attenuate ketamine induced sympathetic stimulation and reduce psychotomimetic effects making the combination of these helpful in opioid sparing.

Primary Objective :

To assess and compare the analgesic efficay with concurrent positive affective symptoms, between three doses of ketamine infusion in combination with dexmedetomidine infusion, at extubation and 30 minutes into post-operative period.

 Secondary Objective :

To compare the recovery profile using the modified Aldrete score between the three groups at extubation and 30 minutes into the post-operative period.

Sedation score using Ramsay sedation scale

Haemodynamic variability between the groups

Postoperative patient’s satisfaction using Likert’s scale

To record presence of nystagmus, diplopia or headache and PONV

Inclusion criteria :

·       Breast conservation oncosurgery patients in age group 18 – 60 years

·       ASA gd 1 - 3

Exclusion criteria :

·       H/o epilepsy

·       Raised ICT, prev. cranial surgery or trauma

·       Pre-op psychosis, schizophrenia

·       Pre-op antipsychotic medication history

·       Active substance abuse

·       Uncontrolled hypertension

·       Allergy

·       Av block patients, cardiac ailments, low EF

·       Significant coronary artery disease

·       Glaucoma / prev. occular surgery

·       Severe liver dysfunction

 Anesthesia technique :

Standard anesthesia induction with Sevoflourane in O­2:Air mixture + Fentanyl @ 1mcg/kg + Propofol @ 1.5 mg/kg + Vecuronium 0.1 mg/kg will be done followed by oral endotracheal intubation with 7.0 mm internal diameter. All patients will be monitored using standard anesthesia monitoring, additionally applying BIS monitoring in all patients.

Anesthesia will be maintained with Sevoflourane in O­2: Air mixture, with Dexmedetomidine 4 mcg/ml infusion @ 0.5 mcg/kg/hr and Vecuronium 0.5 mg/ml infusion adjusted to maintain Train of Four count of 1. A 2 mg/ml Ketamine infusion dose shall be instituted as per the study group assigned randomly.  Intermittent boluses of fentanyl shall be given if either the heart or the blood pressure or both rise 20% above the baseline, as physiological indicators of algesia. All patients will receive pre-emptive analgesia with 1 gm i/v Paracetamol and 75mg Diclofenac in 100 ml normal saline infused at the end of surgery. All patients will be reversed and extubated with Sugammadex 2 mg/kg. The peri-operative questionnaires and  parameters shall be recorded and monitored as per the decided protocol.

 Observation :

CADSS Score (preop & 2-hr post op)

BPRS score

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA1,2 BMI 18–35 kg/m2.

排除标准

  • • H/o epilepsy • Raised ICT
  • Pre-op antipsychotic medication history
  • Uncontrolled hypertension
  • AV block patients, cardiac ailments, low EF
  • Glaucoma, previous ocular surgery.

研究者

发起方
Rajiv Gandhi Cancer Institute and Research Center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Soumi Pathak

Rajiv Gandhi Cancer Institute and Research Center

研究点 (1)

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